Download beva_end_2_opuscolo_eng_gennaio_2017

Study Title
Primary Objective
BEVA END 2:
A randomized phase II trial of Carboplatin-Paclitaxel
compared to Carboplatin-Paclitaxel-Bevacizumab in
advanced (stage III-IV) or recurrent endometrial cancer.
To compare progression-free survival (PFS) of patients with advanced or
recurrent chemonaive endometrial cancer when treated with CarboplatinPaclitaxel vs Carboplatin-Paclitaxel-Bevacizumab.
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Secondary Objectives
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Inclusion Criteria
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Exclusion Criteria
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To compare the overall survival (OS) of patients receiving
Carboplatin-Paclitaxel vs Carboplatin-Paclitaxel- Bevacizumab
To compare the best response rate of patients receiving
Carboplatin-Paclitaxel vs Carboplatin-Paclitaxel-Bevacizumab
To assess the safety and tolerability of Carboplatin-PaclitaxelBevacizumab in this population
To assess changes in Quality of Life parameters in patients treated
with Carboplatin-Paclitaxel compared to those treated with
Carboplatin-Paclitaxel-Bevacizumab.
≥18 years of age.
ECOG Performance Status of 0–2.
Life expectancy of at least 12 weeks.
Patients must have advanced stage III or IV, or recurrent
histologically-confirmed endometrial cancer.
Endometrial cancer will include all carcinomas, including
endometrioid carcinoma, papillary serous carcinoma, clear cell
carcinoma.
One previous chemotherapy lines is allowed if platinum free
interval is more than six mounths (previous radiotherapy is
allowed).
Measurable and not measurable disease.
Adequate renal and hepatic function.
Adequate bone marrow function.
Females of childbearing potential must have a negative serum
pregnancy test within 7 days prior to study enrollment.
Women who are pregnant or lactating.
Presence of brain or other central nervous system metastases.
Inadequate recovery from any prior surgical procedure or having
undergone any major surgical procedure within 4 weeks prior to
randomization. Patients who have recovered from placement of a
central venous access port within 2 weeks of Cycle 1 Day 1 will
be considered eligible.
Another primary malignancy within the past five years (except for
non-melanoma skin cancer and cervical carcinoma in situ).
Current or recent (within 10 days prior to the first study drug
dose) chronic daily treatment with aspirin (>325 mg/day).
Current or recent (within 10 days prior to the first study drug
dose) use of full-dose oral or parenteral anticoagulant or
thrombolytic agent for therapeutic purposes.
Inadequate
coagulation
parameters:
activated
partial
thromboplastin time (APTT) >1.5 xULN or INR >1.5
 Known HIV infection.
 Known hepatitis B or C infection.
 Concurrent treatment with immunosuppressive or investigational
agents.
 History or evidence of thrombotic or hemorrhagic disorders;
including cerebrovascular accident (CVA) / stroke or transient
ischemic attack (TIA) or subarachnoid haemorrhage within _6
months prior to the first study treatment).
 Uncontrolled hypertension (sustained systolic >150 mm Hg
and/or diastolic >100 mm Hg despite antihypertensive therapy) or
clinically significant (i.e. active) cardiovascular disease,
including.
 Myocardial infarction or unstable angina within _6 months prior
to the first study treatment.
 New York Heart Association (NYHA) grade II or greater
congestive heart failure (CHF).
 Serious cardiac arrhythmia requiring medication (with the
exception of atrial fibrillation or paroxysmal supraventricular
tachycardia).
 Peripheral vascular disease _grade 3 (i.e. symptomatic and
interfering with activities of daily living requiring repair or
revision).
 History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to the first study
treatment.
 Non-healing wound, ulcer or bone fracture. Patients with
granulating incisions healing by secondary intention with no
evidence of facial dehiscence or infection are eligible but require
three weekly wound examinations.
 Serious active infection requiring i.v. antibiotics at enrolment.
 Significant traumatic injury during the 4 weeks preceding the first
dose of bevacizumab.
 Known hypersensitivity to any of the study drugs or excipients
(including cremophor and hamster Ovary cell products).
 Evidence of any other medical conditions (such as psychiatric
illness, peptic ulcer, etc.), physical examination or laboratory
findings that may interfere with the planned treatment, affect
patient compliance or place the patient at high risk from treatment
related complications.
Number of Patients to
enroll
For Information
108 /108 enrolled patients
54 Arm A
54 Arm B
Giovanni Scambia
[email protected]
Domenica Lorusso
[email protected]
Trial Office Coordinator
[email protected]