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Breast Cancer
Title: CALGB 40502: A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound
Nab-Paclitaxel or Ixabepilone Combined with Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast
Cancer.
Purpose: To compare the anticancer effects and side effects of these three different chemotherapy drugs given on a weekly schedule in
combination with bevacizumab.
Eligibility Subjects must be 18 years or older with invasive breast cancer; Stage IV or Stage IIB, not agreeable to local therapy.
Principal Investigator: Truica, Cristina
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Breast Cancer
Title: SWOG S0622, Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant
Metastatic Breast Cancer.
Purpose: This study is investigational and is being done to find out if taking the drug dasatinib by mouth by either of two different
dosing schedules will help control cancer and whether it will affect the bones.
Eligibility Patients who have stage IV breast cancer which is bone-predominant. Patients may have 0 to 1 prior chemotherapy regimens
for metastatic disease. Patients who are ER and/or PgR+ must have progressed on at least one hormonal therapy in metastatic
setting. Measurable or non-measurable disease. Zubrod performance status 0-2. Only adults older than 18 can participate.
EKG with OTc<450ms.
Principal Investigator: Truica, Cristina
Phase: II
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Breast Cancer
Title: SWOG S0800: A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (NAB-Paclitaxel)
(NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed By Q 2 Week Doxorubicin (A) and
Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) As Neoadjuvant Therapy for Inflammatory and Locally Advanced
Her-2/Neu Negative Breast Cancer
Purpose: To compare two different treatment regimens for breast cancer prior to surgery to determine which regimen works better and
to compare the type and severity of the side effects of each of the two treatment regimens.
Eligibility Women with confirmed diagnosis of HER-2 negative inflammatory breast carcinoma and must not have received any prior
treatment within the past five years.
Principal Investigator: Truica, Cristina
Phase: II
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Breast Cancer
Title: SWOG S0500: A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for
Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-up Assessment.
Purpose: To find out if the CellSearch blood test, which identifies tumor cells in the blood, can predict survival outcome in patients
with metastatic breast cancer.
Eligibility Patients must be women with histologically confirmed breast cancer and clinical evidence of metastatic disease. Must have
measurable disease or bone-only disease. Patients wilt prior adjuvant chemotherapy must have completed adjuvant at least 12
months prior to registration. Prior hormonal therapy, bisphosphonates, trastuzumab, and/or bevacizumab in metastatic
setting acceptable. Patients must have recovered from prior surgery and HER-2 status determination by IHC and/or FISH
assay.
Principal Investigator: Truica, Cristina
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Breast Cancer
Title: Phase III Trial of Continuous Schedule AC + G Vs. Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2
Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast
Cancer. (SWOG S0221)
Purpose: To compare the effects of four different treatments for breast cancer.
Eligibility Men and women with histologic confirmed diagnosis of operable Stage I, II, or III invasive breast cancer with known ER and
PR status. Had modified radical mastectomy or local excision and axillary lymph node dissection with 6 nodes removed or
sentinel node. Must be registered within 84 days from the final surgical procedure.
Principal Investigator: Truica, Cristina
Phase: III
For more information, contact: Bosley, Judy
Telephone Number: 410-601-4392
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 2
07-02-2010
Breast Cancer
Title: CALGB 40101: Cyclophosphamide and Doxorubicin (CA x 4 Cycles) Versus Paclitaxel (4 Cycles) As Adjuvant Therapy for
Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A Phase III Randomized Study.
Purpose: To compare the effectiveness of the standard adjuvant chemotherapy cancer with the chemotherapy drug paclitaxel. In
addition, we will learn more about the side effects of each treatment, and compare them with each other, in order to measure
the effectiveness and tolerability of the treatments.
Eligibility Histologically confirmed invasive carcinoma of the female breast with 0-3 positive axially lymph nodes.
Principal Investigator: Truica, Cristina
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 2
07-02-2010
Breast Cancer
Title: CALGB 40503 / CTSU 40503: Endocrine Therapy in Combination with anti-VEGF Therapy: A Randomized, Double-Blind,
Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND
7921) For Women with Hormone Receptor-Positive Advanced Breast Cancer.
Purpose: To see if the addition of benvacizumab (Avastin) to standard hormonal therapy can help improve the effectiveness of
hormonal therapy. The study will also look at the good and bad effects of hormonal therapy alone when compared with
hormonal therapy when given in combination with bevacizumab.
Eligibility Subjects must be at least 18 years of age, have Stage IV or Stage IIIB disease, and not have had a currently active second
malignancy.
Principal Investigator: Truica, Cristina
Phase: III
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
07-02-2010
Breast Cancer
Title: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment:
The TAILORx Trial
Purpose: To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal in women whose tumors meet
established clinical guidelines for adjuvant chemotherapy and fall in the "primary study group" category (Oncotype DX
Recurrence Score 11-25). The primary study endpoint is disease-free survival; other co-primary endpoints include distant
recurrence free interval, recurrence free interval, and overall survival. To create a tissue and specimen bank for patients
enrolled in this trial, including formalin fixed paraffin embedded tumor specimens, tissue microarrays, plasma, and DNA
obtained from peripheral blood. This resource will be critical for evaluating emerging Clinical Cancer Tests.
Eligibility Female patients between the ages 18 and 75 with operable histologically confirmed adenocarcinoma of the breast who have
completed primary surgical treatment.
Principal Investigator: Truica, Cristina
Phase: III
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 3
07-02-2010
Breast Cancer
Title: A Randomized Phase III Trial Comparing 16 to 18 weeks of Neoadjuvant Examestane (25 mg daily), Letrozole (2.5 mg), or
Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer.
(ACOSOG Z1031)
Purpose: To find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the change that the breast cancer
will get smaller before surgery.
Eligibility
Principal Investigator: Truica, Cristina
Phase: III
For more information, contact: Bosley, Judy
Telephone Number: 410-601-4392
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 3
07-02-2010
Carcinoma
Title: GOG-0240: A Randomized Phase III Trial of Cisplatin Plus Paclitaxel With and Without NCI-Supplied Bevacizumab (NSC
#704865, IND #7921) Versus the Non-Platinum Doublet, Topotecan Plus Paclitaxel, With and Without NCI-Supplied
Bevacizumab, in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix.
Purpose: To compare the effectiveness, safety, and the impact on health-related quality of life of cisplatin and paclitaxel, cisplatin and
paclitaxel plus bevacizumab, paclitaxel and topotecan, as well as paclitaxel and topotecan plus bevacizumab. Thus, there are
four drug combinations possible
Eligibility Patients must be at least 18 years of age, be diagnosed with new Stage I-IV persistent or recurrent uterine carcinosarcoma,
recovered from recent surgery, radiotherapy or other therapy.
Principal Investigator: Kumar, Pallavi
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Carcinoma
Title: GOG-0261: A Randomized Phase III Trial of Paclitaxel Plus Carboplatin versus Ifosfamide Plus Paclitaxel in
Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal
Tumors) of the Uterus.
Purpose: To compare the drugs, carboplatin and paclitaxel to a standard treatment for uterine cancer (paclitaxel plus ifosfamide and
mesna). Mesna is a protective medication and not an anti-cancer chemotherapy.
Eligibility Patients must be at least 18 years of age, be diagnosed with new Stage I-IV persistent or recurrent uterine carcinosarcoma,
recovered from recent surgery, radiotherapy or other therapy.
Principal Investigator: Kumar, Pallavi
Phase: III
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Chronic Lymphocytic Leukemia
Title: ABT4710n: A Phase II Multicenter, Randomized, Controlled, Open-Label Study of the Safety, Efficacy and
Pharmacokinetics of ABT-263 in Combination with Rituximab in Previously Untreated Patients with B-Cell, Chronic
Lymphocytic Leukemia (CLL)
Purpose: To determine whether the combination of rituximab and ABT-263 is more effective in managing CLL than rituximab alone and
to determine if this combination of medicines is safe and well tolerated. In addition, blood tests will be performed to measure
the concentrations of rituximab and ABT-263 in the subjects blood in order to assess how the body handles theses medicines.
Eligibility Patients referred to the Cancer Institute, 18 years of age or older, who have not been treated for CD20-positive B-cell CLL. A
history of emergency, loco-regional radiotherapy also meets eligibility.
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 15
Current Enrollment: 0
07-02-2010
Colon & Rectal Cancer
Title: Amgen 20080259: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Pegfilgrastim Administered to
Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either
5-Fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-Fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Purpose: To evaluate the effect of Neulasta®, which is needed to stop the white blood cells from decreasing too much during cancer
treatment, and on progression-free and overall survival.
Eligibility Locally-advanced or metastatic colorectal cancer subjects eighteen years of age or older.
Principal Investigator: Yarlagadda, Lavanya
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Colon Cancer
Title: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and
Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic
Value of Molecular Markers. (ECOG E5202)
Purpose: To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned
to 5-FU, leucovorin,, oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab. To compare overall survival between
the regimens, to further define the toxicity profiles of the regimens. To prospectively determine the impact of tumor
biological characteristics on the survival of patients with stage II colon cancer.
Eligibility
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number:
Current Enrollment: 0
07-02-2010
Colorectal Cancer
Title: A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI with Either
Panitumumab or Bevacizumab as Second-line Treatment in Subjects with Metastatic Colorectal Cancer with Wild-Type
KRAS Tumors. (Amgen 20060141)
Purpose: To estimate objective response rate (ORR; complete response [CR] plus partial response [PR]) at weeks 17 and 25 and best
response anytime during second-line treatment (CR vs. PR vs. stable disease [SD] vs. progressive disease [PD] in subjects
with metastatic colorectal cancer (mCRC) reported at any time during second-line treatment with FOLFIRI and either
panitumumab or bevacizumab. To estimate median progression-free survival (PFS) time, PFS at weeks 17 and 25, disease
control response ([CR], [PR], or [SD]) responses, duration of response, and safety in subjects with mCRC receiving
second-line FOLFIRI with either panitumumab or FOLFIRI with bevacizumab.
Eligibility Men and women 18 years of age or older with a diagnosis of metastatic adenocarcinoma of the colon or rectum that cannot be
cured by surgical resection at the time of randomization.
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 1
07-02-2010
Coronary Heart Disease
Title: Antithrombosis with Clopidogrel: Beyond the Concept of Platelet Aggregate Inhibition.
Purpose: To determine the effects of clopidogrel on fibrin, thrombin, and platelet aggregation in patients with coronary artery disease
(narrowing of heart vessels). The effects of clopidogrel on patients with coronary artery disease who have received stents as
opposed to those with coronary artery disease who are on chronic aspirin therapy and have not received the stents will also
be determined.
Eligibility Men and women aged 18 years or older with coronary artery disease are eligible to participate.
Principal Investigator: Gurbel, Paul A.
Phase: I
For more information, contact: Bliden, Kevin
Telephone Number: 410-601-4795
Email [email protected]
Approved Enrollment Number: 100
Current Enrollment: 24
07-02-2010
Diffuse Large B-Cell Lymphoma
Title: A Phase III Multicenter, Open-Label Study of Rituximab Faster Infusion Time in Patients with Previously Untreated Diffuse
Large B-Cell or Follicular Non-Hodgkin's Lymphomas. (U4391g)
Purpose: To determine how well patients tolerate the second and subsequent infusions of rituximab when it is given at a faster rate
(over 90 minutes) than the FDA-approved rate (over 3 to 4 hours).
Eligibility Patients must be over 18 years of age with previously untreated diffuse large B-cell lymphoma who are scheduled to receive
rituximab 375 mg/m2 plus CHOP chemotherapy, or previously untreated follicular non-Hodgkin's lymphoma who are
scheduled to receive rituximab 375 mg/m2 plus CVP chemotherapy. There are also exclusion criteria which will be reviewed
by the principal investigator and/or research nurses.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 4
07-02-2010
Follicular Non-Hodgkin's Lymphoma
Title: SWOG S0801: A Phase II Study of Iodine-131 Labeled Tositumomab in Combination with Cyclophosphamide, Doxorubicin,
Vincristine, Prednisone and Rituximab Therapy for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma
Purpose: To evaluate response rate and toxicity in patients with advanced stage follicular NHL treated with a combination of
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab plus Iodine-131 tositumomab with rituximab
maintenance compared to those patients who just received R-CHOP therapy.
To estimate 3-year and 5-year progression-free survival rate for the regimen.
Eligibility Patients must be 18 year of age or older.
Previous untreated Stage III, IV or bulky Stage II follicular B-cell Non-Hodgkin's lymphoma, positive for CD20
Bone marrow aspiration and biopsy must be performed.
Other eligibility and ineligibility criteria will be reviewed with the patient by the physician or research oncology nurses.
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
07-02-2010
Lung Cancer
Title: CALGB 30610: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer
also Receiving Cisplatin and Etoposide
Purpose: To compare the effects, good and/or bad, of three different ways to give radiation therapy. Two of the ways are experimental,
while one of them is standard.
Eligibility Must have histologically or cytologically documented small cell lung cancer of limited stage. Measurable disease. No prior
chemotherapy or radiotherapy for SCLC.
No prior mediastinal or thoracic radiotherapy. Patients with complete surgical resection of disease are not eligible. Must be
18 years of age or older. ECOG Performance status 0-2. Non-pregnant and non-nursing.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Lung Cancer
Title: SWOG S0819: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with
or without Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Purpose: To treat patients with advanced nonsmall cell lung cancer with carboplatin, paclitaxel and bevacizumab (if appropriate) with
or without cetuximab and to compare the entire study population's overall survival and the progression-free survival by an
institutional review in epidermal growth factor receptor (EGFR) FISH-positive patients.
Eligibility Patients should be 18 years of age or older. Patient must have histologically or cytologically proven newly diagnosed Stage
IV NSCLC.
Patients must not have received prior chemotherapy, cetuximab, gefitinig, erlotinig or other investigational agents that target
EGFR pathway.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Lung Cancer
Title: S0802, "A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in
Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)"
Purpose: To compare the effects, good and/or bad, of topotecan alone with topotecan plus AVE0005 to find out which is better. Also,
to find out more about the effects, good and/or bad, weekly topotecan causes.
Eligibility Subjects must be 18 years or older and have a histologically or cytologically confirmed diagnosis of extensive stage small cell
lung cancer with progression or recurrence after receiving exactly one standard first-line platinum-containing regimen.
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Lung Cancer
Title: Protocol H3E-US-S130: Randomized, Open-Label, Phase 3 Study of Pemetrexed Plus Carboplatin Followed by Maintenance
Pemetrexed Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with
Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology
Purpose: How treatment with pemetrexed plus carboplatin followed by additional pemetrexed compares to treatment with paclitaxel
plus carboplatin plus bevacizumab followed by additional bevacizumab.
Eligibility Anyone 18 years or older with an advanced Stage IV histologic or cytologic diagnosis of NSCLC and may not have received
any prior therapy.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Lymphoma
Title: C05013: An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE
in Previously Untreated Patients with Non-Germinal Center B-Cell-Like Diffuse Large B-Cell Lymphoma.
Purpose: To determine whether the addition of VELCADE to a commonly used drug combination for patients with diffuse large B-Cell
lymphoma called RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) benefits patients with
non-GCB diffuse large B-Cell lymphoma and whether this combination can be given safely.
Eligibility Subjects with previously Untreated Non-Germinal Center B-Cell-Like Diffuse Large B-Cell Lymphoma.
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Lymphoma
Title: Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo
Diffuse Large B-Cell Lymphoma. (CALGB 50303)
Purpose: To compare the effects of two treatments (called R-CHOP with Dose-Adjusted EPOCH-R [DA-EPOCH-R, for short] on
lymphoma to find out which treatment is better. Currently, R-CHOP is considered standard of care.
Eligibility Patients older than 18 years of age with histologically documented de novo CD20+ diffuse large b-cell lymphoma with stage
II, III or IV disease.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 5
07-02-2010
Mantle Cell Lymphoma
Title: A Phase 2, Multicenter, Single-Arm, Open-Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide
(Revlimid) in Patients with Mantle Cell NHL Who Have Relapsed or Progressed After Treatment with Bortezomib or Are
Refractory to Bortezomib. (CC-5013-MCL-001)
Purpose: To determine the tumor response and duration of response of Lenalidomid monotherapy in patients with mantle cell
Lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.
Eligibility Patients who have relapsed or refractory mantle cell non-hodgkin's lymphoma following treatment such as radiotherapy,
immunotherapy, chemotherapy, or radioimmunotherapy.
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Bosley, Judy
Telephone Number: 410-601-4392
Email [email protected]
Approved Enrollment Number: 8
Current Enrollment: 0
07-02-2010
Mantle Cell Lymphoma
Title: 26866138-LYM-3002: A Randomized, Open-Label, Multicentre Phase 3 Study of the Combination of Rituximab,
Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin,
Vincristine, and Prednisone (R-CHOP) in Patients with Newly Diagnosed Mantle Cell Lymphoma who are not Eligible for a
Bone Marrow Transplant.
Purpose: To determine which regimen of chemoRx, VELCADE (bortezomid) plus VcR-CAP or R-CHOP provides most benefit to
newly diagnosed mantle cell lymphoma patients in terms of progression free survival. To determine overall survival, time to
progression, 18 month survival rate, overall response, duration of response, time to subsequent therapy, and to compare
safety of the 2 regimens. Also to complete a biomarker research study.
Eligibility Male and female patients 18 years of age or older with a diagnosis of mantel cell lymphoma (stage II, III or IV) with at least 1
measurable site of disease. Patient had no prior therapies for mantel cell lymphoma.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 2
Current Enrollment: 0
07-02-2010
Melanoma
Title: Phase III Randomized Study of Four Weeks High Dose IFN-Alfa2b in Stage T3-T4 or N1 (microscopic) Melanoma. (SWOG
E1697)
Purpose: To compare the effect of treatment with 4 weeks of high dose IFN-Alfa2b on the relapse free survival and overall survival of
patients with resected melanoma; assess the toxicity of high dose IFN-Alfa2b; and compare two treatment arms.
Eligibility
Principal Investigator: Didolkar, Mukund S.
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number:
Current Enrollment: 6
07-02-2010
Myeloma
Title: S0777, "A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD)
Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients
with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant"
Purpose: Comparing the two different combinations of drugs, LLD with BLLD, to evaluate whether they can stop or slow down the
progression of untreated multiple myeloma, and if so, which one is more effective.
Eligibility Subjects 18 + years old with newly diagnosed multiple myeloma and must not have received any prior therapy.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Nausea
Title: Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/Dexamethasone with or without Dronabinol for the
Prevention of Chemotherapy-induced Nausea and Vomiting after Moderately Emetogenic Chemotherapy. (MDA 2006-0841)
Purpose: To determine whether dronabinol can add significantly to the antiemetic protection provided by a standard palonosetron and
dexamethasone regimen for patients receiving moderately emetogenic chemotherapy. To determine the tolerability of
dronabinol when added to a regimen of dexamethasone and palonosetron administered for the prevention of acute and delayed
nausea and vomiting caused by moderately emetogenic chemotherapy. Tolerability will be evaluated by investigating whether
there are treatment-limiting toxicities observed with three drug combination.
Eligibility Patients 18 years of age or older with histologically or cytologically documented solid tumor receiving chemotherapy for the
first time.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 2
07-02-2010
Non-Hodgkin's Lymphoma
Title: PALO-08-09: Multicenter, Phase IV, Open-Label, Uncontrolled Study to Assess the Efficacy and Safety of a Single
Intravenous Dose of Palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in the Prevention of Chemotherapy-Induced Nausea
and Vomiting in Patients with Non-Hodgkin's Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic
Chemotherapy.
Purpose: To find out the effectiveness and safety of single doses of intravenous (IV through a vein)Palonosetron 0.25 mg (commercial
names: Aloxi ®, Onicit ® or Paloxi ® in the prevention of moderately emetogenic Chemotherapy Induced Nausea and
Vomiting (CINV) in repeated and consecutive single day moderately emetogenic chemotherapy cycles administered to
Non-Hodgkin's Lymphoma patients.
Eligibility Those that would be eligible would be males or females, greater than 18 years of age, histologically or cytologically confirmed
Non-Hodgkin's Lymphoma, must be scheduled to receive single-day MEC as one of the following regimens in at least two
repeated and consecutive chemotherapy cycles: CHOP or R-CHOP or ProMACE-CytaBOM. Also must be naïve to cancer
chemotherapy, a Kamofsky performance status of >50% at each study cycle and a patient with a known hepatic, renal or
cardiovascular impairment including cardiac conduction interval abnormalities and scheduled to receive the above
chemotherapeutic agents.
Principal Investigator: Noga, Stephen
Phase: IV
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
07-02-2010
Non-Small Cell Lung Cancer
Title: AC01L08: A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination with Platinum-Based
Chemotherapy as First Line Treatment of Patients with Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)
Purpose: Testing the investigational drug Cetuximab, in combination with different chemotherapy drugs for lung cancer. To determine
which of the combinations looks most promising for the treatment of the disease and if it should be tested further.
Eligibility Subjects 18 years of age or older with confirmed Stage IIIb
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Hagy, Melissa
Telephone Number: 410-601-9083
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 2
07-02-2010
Ovarian Cancer
Title: GOG-0252: A Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy in Ovarian, Fallopian Tube, and
Primary Peritoneal Carcinoma
Purpose: To compare IV chemotherapy with two different IP treatment regimens to determine if there is a survival benefit. The study
will also collect information on side effects and possible complications from IP administration. The study will also compare
how different types of cancer respond to one of three different chemotherapy regimens when given with the new drug,
Bevacizumab (Avastin).
Eligibility Patients must be 18 years of age, have a diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, Stage
II, III, or IV with either optimal disease or suboptimal residual disease.
Principal Investigator: Kumar, Pallavi
Phase: III
For more information, contact: Bonvegna, Rosemarie
Telephone Number: 410-601-6120
Email [email protected]
Approved Enrollment Number: 8
Current Enrollment: 0
07-02-2010
Prostate Cancer
Title: Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer:
Homogenous Dose Distribution. (ACCP001.2)
Purpose: To determine the effects of CyberKnife radiosurgery in patients with prostate cancer. To evaluate the effect of this treatment
on subject's quality of life over time.
Eligibility Subjects with histologically proven prostate adenocarcinoma. Clinical state %1b-T2b, N0-Nx, M0-Mx. PSA equal to or less
than 20 ng/ml. Subjects belonging in one of the following risks groups: Low: CS T1b-T2a and Gleason 2-6 and PSA equal to
or less than 10, or Intermediate: CS T2b and Gleason 2-6 and PSA equal to or less than 10, or CS T1b-T2b, and Gleason 2-6
and PSA equal to or less than 20 ng/ml, or Gleason 7 and PSA equal to or less than 10 ng/ml 2-6 and PSA equal to or less than
20 ng/ml, or Gleason 7 and PSA equal to or less than 10 ng/ml. Call for additional eligibility requirements.
Principal Investigator: Linder, Jeanette AF
Phase: III
For more information, contact: Bosley, Judy
Telephone Number: 410-601-4392
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 6
07-02-2010
Refractory Multiple Myeloma
Title: An Open-Label Study of Bendamustine Combined with Bortezomib for Patients with Relapsed/Refractory Multiple
Myeloma. Phase 1/Phase 2. (C18083/1063/MM/US)
Purpose: To assess the safety and effectiveness of bendamustine and bortezomib (Velcade) administered as combination therapy for the
treatment of relapsed/refractory multiple myeloma.
Eligibility Patient has a diagnosis of multiple myeloma.
Principal Investigator: Noga, Stephen
Phase: I/II
For more information, contact: Bosley, Judy
Telephone Number: 410-601-4392
Email [email protected]
Approved Enrollment Number: 4
Current Enrollment: 1
07-02-2010
Renal Cell Carcinoma
Title: ECOG E2804: The BeST Trial: A Randomized Phase II Study of VEGF, RAF kinase, and mTOR Combination Targeted
Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma.
Purpose: To compare the effects, good and/or bad of several different treatments on the patient and the patient’s metastatic renal cell
carcinoma.
Eligibility Patients must be at least 18 years of age and meet certain criteria with respect to the size of the tumor, measurable metastatic
disease not curable by standard radiation therapy or surgery. There should be no history of CNS disease including primary
brain and no history of stroke within the previous 48 weeks. The study doctor will review all eligibility criteria and evaluate
the patient for any exclusion criteria before they can participate.
Principal Investigator: Noga, Stephen
Phase: II
For more information, contact: Bosley, Judy
Telephone Number: 410-601-4392
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
07-02-2010
Small Cell Lung Cancer
Title: A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients with Extensive
or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy. (AMR pH GL 2007
CL 001)
Purpose: To demonstrate superiority in overall survival of amrubicin (40 mg/m2 administered as a 5-minute infusion once daily for 3
consecutive days starting on Day 1 of a 21-day course) compared with topotecan hydrochloride (topotecan) (1.5 mg/m2
administered as a 30-minute infusion once daily for 5 consecutive days starting on Day 1 of a 21-day course) in patients with
extensive or limited and sensitive or refractory small cell lung cancer (SCLC) after failure of first-line chemotherapy. The
important secondary objectives are to further characterize the clinical benefit of amrubicin compared with topotecan in terms
of objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST), progression-free survival
(PFS), and duration of response.
Eligibility Subjects at least 18 years of age with no more than 1 prior chemotherapy regimen.
Principal Investigator: Noga, Stephen
Phase: III
For more information, contact: Bosley, Judy
Telephone Number: 410-601-4392
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 2
07-02-2010