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SANDHYA SRINIVAS, M.D. Associate Professor of Medicine (Oncology) Stanford University Medical Center 875 Blake Wilbur Drive Stanford, CA 94305-5826 Work: (650) 725-2078 Personal History Birthplace Date of Birth Citizenship Education 1980-1986 1987-1989 1989-1991 1992-1995 Positions Held 1986-1987 1996-1997 1997-1999 6/01/99-8/31/99 9/01/99-8/31/02 9/01/02-8/31/03 9/01/03-8/31/06 9/01/06-8/31/11 Vellore, India March 19, 1962 U.S. M.B.B.S. - Madras Medical College, India Clinical Sub-intern Strong Memorial Hospital Cancer Center, Rochester, NY Internship and Residency, Internal Medicine, St. Mary’s Hospital, Rochester, NY Postdoctoral Fellowship, Oncology University of California, San Francisco, San Francisco, CA Research Assistant Department of Microbiology University of Rochester Medical Center, Rochester, NY Assistant Clinical Professor of Medicine VA Medical Center, Houston Baylor College of Medicine, Houston, TX Clinical Instructor Veterans Affairs Palo Alto Health Care System Stanford University Medical Center, Stanford, CA Acting Assistant Professor of Medicine (Oncology) Veterans Affairs Palo Alto Health Care System Stanford University Medical Center, Stanford, CA Assistant Professor of Medicine (Oncology) Veterans Affairs Palo Alto Health Care System Stanford University Medical Center, Stanford, CA Assistant Professor of Medicine (Oncology) (extension) Veterans Affairs Palo Alto Health Care System Stanford University Medical Center, Stanford, CA Assistant Professor of Medicine (Oncology) Stanford University Medical Center, Stanford, CA Associate Professor of Medicine (Oncology) Stanford University Medical Center, Stanford, CA 1 Professional Certification 1987 ECFMG 1988 FLEX 1991 Medical License: California A049392 1992 Board Certified: Internal Medicine 1995 Board Certified: Hematology 1997 Board Certified: Oncology 2001 Recertification: Internal Medicine 2009 Recertified: Medical Oncology Academic Memberships 1996American Society of Clinical Oncology 2002Association of Northern California Oncologists Committees 1996 Residency Selection Committee, Baylor College of Medicine, Houston, TX 1997-2003 Blood Transfusion Committee 1997-2003 Veterans Affairs Palo Alto Health Care Services Cancer Care Committee 2002National Comprehensive Cancer Network Prostate Committee 2002Data Safety Monitoring Committee, Stanford Cancer Center 2002Intern Selection Committee, Department of Medicine, Stanford University 2005-2008 CME Sub Committee, American Society of Clinical Oncology 2007Co-director, Med X, Oncology Inpatient Service, Stanford Hospital & Clinics 2010Board of Directors, Association of Northern California Oncologists Awards: 2002 2003 2003 2004 2006 2007 2008 2009 Oncology Clinical Fellows’ Teaching Award Medicine Chief Residents Teaching Award Oncology Clinical Fellows’ Teaching Award Oncology Clinical Fellows’ Teaching Award Oncology Clinical Fellows’ Teaching Award Oncology Clinical Fellows’ Teaching Award Oncology Clinical Fellows’ Teaching Award Oncology Clinical Fellows’ Teaching Award Invited Papers & Presentations Local 1997 Hormone Use in Prostate Cancer - Stanford Medical Center 1997 Carcinoma Unknown Primary - Stanford Medical Center 2000 What’s next after hormones in prostate cancer – Spago’s, Palo Alto 2000 Advanced Testicular Cancer - Stanford Medical center 2000 Chemotherapy in prostate cancer - Emile’s, San Jose 2001 Prostate Cancer, Lane Lecture Series - Stanford, CA 2001 Small Cell Lung Cancer - Stanford Medical Grand Rounds 2 2002 2002 2002 2004 2004 2005 2005 2005 2005 2006 2007 2008 2009 2010 Regional 1999 1999 2000 2001 2001 2002 2002 2002 2003 2003 2003 2003 2004 2004 2004 2004 2004 2005 2005 2006 2006 2006 2006 2007 Controversies in Hormonal Therapy in Prostate Cancer - Stanford Medical Center Hormones and Prostate Cancer - Stanford Medicine Grand Rounds Prostate Tumor Board – Spago’s, Palo Alto, CA Node Positive Bladder Cancer - Urology Grand Rounds, Stanford, CA Advanced Bladder Cancer - Stanford Medical Center Clinical Trials in Urologic Oncology - Stanford, CA Metastatic Renal Cell Cancer - Stanford Medical Center Prostate Cancer, Round Table Discussions, Menlo Park, CA ASCO Update in Urologic Oncology - Stanford Medical Center Palliative Care-Oncologic Emergencies, Stanford University, CA Metastatic Renal Cell Cancer- Urology Grand Rounds, Stanford ASCO Update in Urologic Oncology - Stanford Medical Center ASCO Update in Urologic Oncology - Stanford Medical Center ASCO Update in Urologic Oncology - Stanford Medical Center Advances in Testicular Cancer - CME Conference at Napa, CA Advanced Metastatic Prostate Cancer - Clairemont, Oakland GU tumor Board - UCSF/Stanford CME conference, Napa, CA GU tumor Board - UCSF/Stanford CME conference, Napa, CA Advanced Bladder Cancer - Annual Urology Symposium, Palo Alto, CA GU tumor Board - UCSF/Stanford CME conference, Napa, CA Adjuvant Therapy in Bladder Cancer-A careful standard - Annual Urology Symposium, Palo Alto, CA Chemotherapy for Stage I NSGCT - Annual Urology Symposium, Palo Alto, CA Second Line Hormones in Prostate Ccancer - Annual Urology Symposium, Palo Alto, CA Novel Therapies in Advanced Prostate Cancer - Annual Urology Symposium, Palo Alto, CA GU tumor Board - UCSF/Stanford CME conference, Napa, CA Renal Cell Carcinoma - Abgenix, Fremont, CA Adjuvant Chemotherapy - High Risk Prostate cancer. Annual Urology Symposium, Palo Alto, CA GU tumor Board - UCSF/Stanford CME conference, Napa, CA Renal Cell Carcinoma - Genentech, CA Invasive Bladder Cancer - Hoag Cancer Center, CA Advanced Prostate Cancer - St Josephs Hospital, Orange, CA GU tumor Board – UCSF/Stanford CME conference, Napa, CA Taxanes in Prostate Cancer - Annual Urology Symposium, Palo Alto, CA Metastatic Renal Cell Cancer - Visalia, CA Node positive Prostate Cancer - Annual Urology Symposium, Palo Alto, GU Tumor Board - UCSF/Stanford CME conference, Napa, CA New Drugs in Renal Cancer - Annual Urology Symposium, Palo Alto, CA Bladder Cancer - St Joseph’s Hospital, Stockton, CA 3 2007 2007 2008 2009 2009 2010 2010 National 1995 1995 1995 1995 1999 2002 2003 2005 2006 2007 2007 2007 2008 2008 2009 2010 2010 International 2005 2006 2007 2008 2009 GU Tumor Board – UCSF/Stanford CME conference, Napa, CA Kidney Cancer - California Kidney Cancer Foundation, San Francisco, CA ASCO GU Update, ANCO - San Francisco, CA ASCO GU Update, Scripps Clinic - San Francisco, CA Chemotherapy and bladder cancer, BCAN - San Francisco, CA ASCO GU Update, Scripps Clinic - San Francisco, CA Prostate Cancer- New Therapy - Oncology Congress, San Francisco, CA Antiandrogen withdrawal syndrome - American Urologic Association Meeting, San Francisco, CA Doxorubicin and dose escalated cyclophosphamide with Granulocyte colony stimulating factor support for hormone refractory prostate cancer” - Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA Hormonal Therapy in Prostate Cancer - VA Grand Grounds, Houston, TX Use of Tumor Markers - Grand Rounds, Baylor School of Medicine, Houston, TX Management choices in Stage I NSGCT - Annual meeting of American Society of Clinical Oncology, Atlanta, GA Metastatic Bladder & Prostate Cancer - UCD Fellow Symposium, Davis, CA Prostate Cancer - Colorado Springs, Denver, CO Bone Related Events in High Risk Prostate cancer - San Francisco, CA Continuous dosing sunitinib in RCC - Kidney Cancer Symposium, Chicago, IL Metastatic Renal Cell Cancer - Grand Rounds Methodist Hospital, Houston, TX Targeted Therapy - Clinical Symposium, ASCO, Chicago, IL Targeted Therapy in Kidney Cancer - National Comprehensive Cancer Network, Palo Alto, CA Bladder Cancer - Western Section, American Urologic Association, Monterey, CA Kidney Cancer - Wayne State, Michigan Kidney Cancer - Kona, HI Kidney Cancer - La Junta, CO Kidney Cancer, VA Medical Center - Amarillo, TX Metastatic Renal Cell Cancer, Singapore General Hospital International Global Forum: Manila & Hong Kong New Drugs in Kidney Cancer, Mumbai, India Kidney Cancer, Beijing Hormonal Therapy in Prostate Cancer, National Comprehensive Cancer Network, Abu Dhabi Journal Reviewer 2004 Adhoc reviewer, Journal of Urology 2005 Adhoc reviewer, Cancer 2006 Adhoc reviewer, Journal of Urology 4 2007 2008 2009 Adhoc reviewer, Journal of Urology Adhoc reviewer, Journal of Clinical Oncology Adhoc reviewer, Cancer Publications (50 total; 48 published, 1 accepted, 1 submitted): 1. Raschke RA, Reilly BM, Guidry FR, Fontana JR, Srinivas S. The weight-based heparin dosing nomogram compared with a standard care nomogram. A randomized controlled trial. Ann Intern Med 119: 874, 1993. 2. Reilly BM, Raschke R, Srinivas S, Nieman T. Intravenous heparin dosing: patterns and variations in internists practices. J General Internal Medicine 8: 536-42, 1993. 3. Small EJ, Srinivas S. Antiandrogen withdrawal syndrome. Experience in a large cohort of unselected patients with advanced prostate cancer. Cancer 76: 1428-34, 1995. 4. Small EJ, Srinivas S, Egan B, McMilan A, Rearden TJ. Doxorubicin and dose escalated cyclophosphamide with granulocyte colony stimulating factor support for the treatment of hormone resistant prostate cancer . J Clin Oncol 14: 1617-25, 1996. 5. Srinivas S, Freiha FS. Mahalati K. Methotrexate tolerance in ileal conduits and neobladders. Cancer 82: 1134-6, 1998. 6. Srinivas S, Freiha FS. Actinomycin D revisited in testicular cancer. A case report. Tumori 85: 79-80, 1999. 7. Rubin DL, Gennari JH, Srinivas S, Yuen A, Kaizer H, Mausen MA, Silva JS. Tool support for authorizing eligibility criteria for cancer trials. Proc AMIA Symp 1999: 369-73. 8. Srinivas S, Varadhachary G. Spontaneous pneumothorax in malignancy: A case report and review of the literature. Ann Oncol 11:887-9, 2000. 9. Srinivas S. High dose chemotherapy in germ cell tumors. Oncology 14:1419-23, 2000. 10. Durski JM, Srinivas S, Segall G. Comparision of FDG-PET and bone scans for detecting skeletal metastases in patients with non-small cell lung cancer. Clin Positron Imaging 3:97-105, 2000. 11. Srinivas S. Terris MK. Management choices in stage I non-seminomatous. Germ Cell Tumor UroOncology, 2001 1; 1-4 5 12. Kiratli BJ, Srinivas S, Perkash I, Terris MK. Progressive decrease in bone density over 10 years of androgen deprivation therapy in patients with prostate cancer. Urology 57: 127-32, 2001. 13. Srinivas S. Utility of bone scan post primary therapy in prostate cancer. UroOncology, 2:37-39, 2002. 14. Srinivas S, Jain.M, Segall G. Residual masses post chemotherapy in germ cell tumors: role of fluorodeoxyglucose positron emission tomography scans. UroOncology, 2:153-55, 2002. 15. Wren SM, Stijns P, Srinivas S. Positron emission tomography in the initial staging of esophageal cancer. Arch Surg 137:1001-6, 2002. 16. Morgan K, Srinivas S, Freiha F. Synchronous solitary metastases of transitional cell carcinoma to the testis. Urology 64:808-9, 2004. 17. Murphy JC, Srinivas S, Terris MK. Flutamide administration at 500 mg daily has similar effects on serum testosterone to 750 mg daily. J Androl 25:630-634, 2004. 18. Srinivas S, Guardino AE. A non-platinum combination in metastatic transitional cell carcinoma. Am J Clin Oncol. 28:114-8, 2005. 19. Srinivas S, Guardino AE. A lower dose of thalidomide is better than a high dose in metastatic renal cell carcinoma. BJU Int. 96: 536-9, 2005. 20. Srinivas S, Freiha F. Node Positive Bladder Cancer. Arab J Urology 3, 7-11, 2005. 21. Badger J, Kang S, Uzieblo A, Srinivas S. Photorecall with gemcitabine following UVB therapy. J Clin Oncol 23: 7224-5, 2005. 22. Srinivas S, Colocci N, Feldman D. A phase II study evaluating oral triamcinalone in patients with androgen independent prostate cancer. Urology 67:1001-6, 2006. 23. Srinivas S, Colocci N. Bone related events in high risk prostate cancer. Review. J Urol 176:S50-4, 2006. 24. Srinivas S. Colocci N. Non-platinum combinations in advanced bladder cancer. Expert Rev Anticancer Ther 6:887-94, 2006. 25. King CR, McNeal JE, Gill H, Brooks JD, Srinivas S, Presti JC, Jr. The reliability of small amounts of cancer in prostate biopsies to reveal the pathologic grade. Urology 67: 1229-36, 2006. Contributed to the design of the study, analyze the data and the manuscript 6 26. Liu IJ, Lai YH, Espiritu JI, Segall GM, Srinivas S, Nino-Murcia M, Terris MK. Evaluation of fluorodeoxyglucose positron emission tomography imaging in metastatic transitional cell carcinoma with and without prior chemotherapy. Urol Int 77: 69-75, 2006. Contributed to the original idea, helped with patient identification and analyze the results 27. Li M, Srinivas S. Acute pancreatitis associated with sorafenib. South Med J 100: 909, 2007. 28. Bukowski RM, Kabbinavar FF, Figlin RA, Flaherty K, Srinivas S,Vaishampayan U,Drabkin H, Dutcher J,Ryba S,Xia O,Scappaticci FA, and McDermott D. Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cancer. J Clin Oncol 25:4536-41, 2007. Limited multiinstituitional trial; authorship based on number of patients enrolled. 29. Feldman D, Krishnan A, Moreno J, Swami S, Peehl D, Srinivas S. Vitamin D inhibition of the prostaglandin pathway as therapy for prostate cancer. Review. Nutr Rev: 65: S113-5, 2007. 30. Mohler J, Babaian RJ, Bahnson RR, Boston B, D'Amico A, Eastham JA, Hauke RJ, Huben RP, Kantoff P, Kawachi M, Kuettel M, Lange PH, Logothetis C, MacVicar G, Pollack A, Pow-Sang JM, Roach M 3rd, Sandler H, Shrieve D, Srinivas S, Twardowski P, Urban DA, Walsh PC; National Comprehensive Cancer Network. Prostate cancer. Clinical practice guidelines in oncology.J Natl Compr Canc Netw: 7: 650-83, 2007. 31. Harshman LC, Srinivas S. Current status of cytoreductive nephrectomy in metastatic renal cell carcinoma. Expert Rev Anticancer Ther. 7:1749-61, 2007. 32. Harshman LC, Mingqing Li, Srinivas S. The combination of thalidomide and capecitabine in metastatic renal cell carcinoma---is not the answer. Am J Clin Oncol 31:417-423, 2008. 33. Telli ML, Witteles RM, Fisher GA, Srinivas S. Cardioxicity associated with the cancer therapeutic agent sunitinib malate. Ann Oncol. 19: 1613-8, 2008. 34. Jonasch E, Stadler WM, Bukowski RM, Hayes TG, Varadhachary A, Malik R, Figlin RA, Srinivas S. Phase 2 trial of talactoferrin in previously treated patients with metastatic renal cell carcinoma. Cancer 113: 72-7, 2008. 7 35. Srinivas S, Feldman D. A phase II trial of calcitriol and naproxen in recurrent prostate cancer. Anticancer Res. 2009 Sep;29(9):3605-10 36. Agarwal R, Dvorak CC, Stockerl-Goldstein KE, Johnston L, Srinivas S. High dose chemotherapy followed by stem cell rescue for high risk germ cell tumors: the Stanford experience. Bone Marrow Transplant. 2009 Apr;43(7):547-52 37. Escudier B, Johannsen M, Gillessen S, Harmenberg U, Srinivas S, Mulder S, Fountzilas G, Peschel C, Flodgren P, Maneval E, Chen E, Vogelzang N. A phase II study of sunitinib administered in a continuous once-daily dosing regimen in patients with cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol. 2009 Sep 1;27(25):4068-75. Epub 2009 Aug 3. Limited multi instituitional trial; involved in trial design and recruitment of patients and analyzing the data. 38. Krishnan AV, Srinivas S, Feldman D. Combination therapy with calcitriol and non-steroidal anti-inflammatory drugs in the treatment of prostate cancer. Dermato Endocrinolgy 2009; 1: 7-11 I was the PI on a clinical trial using this combination. Shared the trial information and the data as part of this paper 39. Vaughn DJ, Srinivas S, Stadler WM, Pili R, Petrylak D, Sternberg CN, Smith DC, Ringuette S, Wit ED, Pautret V, and George C. Vinflunine in Platinum-Pretreated Patients with Locally Advanced or Metastatic Urothelial Carcinoma: Results of a Large Phase 2 Study. Cancer. 2009 Jun 17 Limited multi instituitional trial; involved in trial design and recruitment of patients and analyzing the data 40. Harshman LC ,Kuo CJ,Wong BY, Vogelzang NJ, Srinivas S. Increased Hemoglobin Associated with VEGF Inhibitors in Advanced Renal Cell Carcinoma. Cancer Invest. 2009 Jul 13:1 41. Srinivas S, & Harshman LC.A Phase II study of docetaxel and oxaliplatin for second line treatment of transitional cell carcinoma of the urothelium. Chemotherapy. 2009 Jul 27;55(5):321-326 42. Harshman LS, Srinivas S, and Chung . Laparoscopic Radical Nephrectomy after Caval Tumor Thrombus Shrinkage with Sunitinib. Nat Rev Urol. 2009 Jun;6(6):338-43. Helped with design, identifying patients 8 43. Gralow JR, Biermann, SJ, Farooki A, Fornier MN, Gagel RF, Kumar RN, Shapiro CL, Shields A, Smith MR, Srinivas S and Van Poznack CH. NCCN Task Force Report: Bone Health in cancer care; JNCCN 2009 44. Harshman LC, Bepler G, Zheng Z, Higgins JP, Allen GI , Srinivas S. RRM1 expression in muscle invasive locally advanced urothelial cancer may correlate with age. BJU Int. 2010 Apr 28. 45. Pili R, Rosenthal MA, Van Hazel G, Srinivas S, Dreicer R, Goel S, Leach J, Wong S and Clingan P. Randomized Phase II Study of the Addition of ASA404 (Vadimezan, 5,6 Dimethylxanthenone-4-acetic acid/DMXAA) to Docetaxel in Castration-Refractory Metastatic Prostate Cancer. Clin Cancer Res. 2010 May 15;16(10):2906-14. Limited multi instituitional trial; involved in trial design and recruitment of patients and analyzing the data 46. Yu JR, Harshman LC, Gill HS, Srinivas S, and Chung BI. Surgical Complications Associated with Presurgical Tyrosine Kinase Inhibition Prior to Cytoreductive Surgery for Advanced Renal Cell Carcinoma. Submitted European Urology Helped with design, identifying patients 47. Dreicer R, Garcia J, Rini B, Vogelzang N, Srinivas S, Somer B, Zhao YD, Kania M, Raghavan D. Oral enzastaurin in prostate cancer: A two cohort phase II trial in patients with PSA progression in the non-metastatic castrate state and following docetaxel-based chemotherapy in the castrate metastatic setting. Investigational New Drugs, Apr 6 2010. Participated in the trial design, recruitment of patients 48. Mohler J, Bahnson RR, Boston B, Busby JE, D'Amico A, Eastham JA, Enke CA, George D, Horwitz EM, Huben RP, Kantoff P, Kawachi M, Kuettel M, Lange PH, Macvicar G, Plimack ER, Pow-Sang JM, Roach M 3rd, Rohren E, Roth BJ, Shrieve DC, Smith MR, Srinivas S, Twardowski P, Walsh PC. NCCN clinical practice guidelines in oncology: prostate cancer.J Natl Compr Canc Netw. 2010 Feb;8(2):162-200 49. Sonn GA, Shinghal R, Yu JR, Chung BI, Srinivas S, Presti JC Jr., and Leppert JT. Kidney Cancer Outcomes in the VA health Care System: Analaysis of 12,112 Patients from the VA Central Cancer Registry. (submitted) Contributed to the idea, analysis of the data 50. Nadauld LD, Miller MB & Srinivas S. Pyoderma Gangrenosum with the Use of Sunitinib. J Clin Oncol (accepted) 9 Non Peer Reviewed (2 total, 1 published, 1 accepted) 1. Harshman LC, Srinivas S. Continuous therapy of sunitinib in patients with metastatic renal cell cancer. Editorial. Onkologie 31:432-433, 2008. 2. Harshman LC , and Srinivas S. The bevacizumab experience in advanced renal cell carcinoma. Oncology Targets and Treatment (accepted) Book Chapters (5) 1. Srinivas S. Second line hormonal therapy in Prostate Cancer (2003). American Cancer Society Atlas of Clinical Oncology, Prostate Cancer. 2. Srinivas S. Urologic Complications of Cancer Treatment- (2004) Springer -Verlag Oncology: An Evidence Based Approach 3. Yamada Y, Harshman LC, Schefter T, Rabinovitch RA, Chung BI, Srinivas S. (2008) Cancer of the kidney. In: The Textbook of Radiation Oncology, 3rd Edition. S. Leibel and T.L. Phillips, eds. Philadelphia, Elsevier 4. Harshman LC, Srinivas S, Symanowski J, Vogelzang NJ. (2008) Formulating the questions and objectives. In: Fundamentals of Oncology Clinical Trials: The Art and Science Behind Successful Clinical Trials. K. Kelly and S. Halabi, eds. New York, Demos Medical Publishing. 5. Presti J, Srinivas S & King C. (2008)Cancer of the Testes. In: The Textbook of Radiation Oncology, 3rd Edition. S. Leibel and T.L. Phillips, eds. Philadelphia, Elsevier 10 Abstracts (38): 1. Small EJ, Ernest ML, Srinivas S. The use of Carboplatin instead of cisplatin in the treatment of advanced Transitional cell Carcinoma(TCC), Amer. Urol. Assoc. Ann. Meeting, 1994. 2. Small EJ, Reardon T, Srinivas S .Doxorubicin and dose escalated cyclophosphamide with Granulocyte colony stimulating factor support for hormone refractory prostate cancer, Proc Amer Soc Clin Onol, 1994. 3. Small EJ, Srinivas S. Effect of prior radiotherapy on response and survival in hormone refractory prostate cancer patients, Proc Amer Soc Clin Onol, 1994. 4. Srinivas S, Freiha F, Segall G.PET in evaluation of residual masses in testicular cancer; Proc Amer Soc Clin Onol #1327;1998 5. Srinivas S, Terris M. Management choices in Stage I NSGCT: Proc Amer Soc Clin Onol, 1999 6. Vempaty H, Srinivas S. Cisplatin in Elderly; Proc Amer Soc Clin Onol 1999 7. Terris MK, Srinivas S. Comparative study of the clinical efficacy of three dosing regimens of Flutamide. AWUA, 1999 8. Kiratli JB, Srinivas S, Terris MK. Effect of androgen deprivation on bone density in prostate cancer patients. AWUA,1999 9. Srinivas S. Bone scan utility in Prostate cancer post primary Therapy. Proc Amer Soc Clin Onol , 2000 10. Srinivas S. Thalidomide in metastatic renal cell carcinoma. Proc Amer Soc Clin Onol , 2001 11. Guardino AE, Srinivas S. Phase II trial of Gemcitabine and Paclitaxel Chemotherapy for Advanced Urothelial Malignancies. Proc Amer Soc Clin Onol 2002 12. Hart L, Redfern C, Srinivas S, Saltzman M, Baron A, Atiba J, Strupp J, Christie R, Schliebner S, Ryan K, Sandler A, Sing A, Ahmann F. A phase II study of SGN-015 combined with docetaxel in patients with hormone refractory prostate carcinoma. Proc Amer Soc Clin Onol 2002 13. Srinivas S and Guardino AE. Randomized phase II trial of high and low dose thalidomide in metastatic renal cell carcinoma. Proc Amer Soc Clin Onol, 2002 11 14. Srinivas S., Beck J.T., Vesole D., McEwen C., Bhatnagar A., and Valone F. Initial Results of a Phase I/II Study of Gallium Maltolate in Patients with Various Refractory Malignancies. EORTC 2002, Germany. 15. Redfern CH, Hart L, Srinivas, S, Hall S, McCune D, Boyd T, Sandler AS, Sing AP, Siegall C, Ahmann FR. A phase II study of SGN-15 (cBR96-doxorubicin immunoconjugate) combined with docetaxel in patients with hormone refractory prostate carcinoma (HRPC). Proc Amer Soc Clin Onol, 2003 16. Lum BL, Srinivas S, Beck JT, Vesole D, Largey M, Valone FH, Sayre PH. Phase I trial of oral gallium maltolate in refractory malignancies. Proc Amer Soc Clin Onol, 2003 17. Freiha FA, Srinivas S. Invasive Renal Pelvis Transitional Cell Carcinoma. Proc Amer Soc Clin Onol, 2004 18. Guardino AE, Srinivas S. Gemcitabine and Paclitaxel Chemotherapy Effective for Good Risk Advanced Urothelial Malignancies. Proc Amer Soc Clin Onol, 2004 19. Srinivas S, Balu V, King C. Utility of Serum prostate specific antigen Doubling time (PSADT) in patients with Androgen Independent Prostate Cancer. Proc Amer Soc Clin Onol, 2005 20. Srinivas S, Colocci N, Feldman D. A phase II study evaluating oral Triamcinalone in patients with androgen independent prostate cancer. Proc Amer Soc Clin Onol, 2005 21. Pachynski RK, King CR, Srinivas S. Prostate Specific Antigen Doubling Time (PSADT) in Patients with Hormone Refractory Prostate Cancer (HRPC) undergoing Docetaxel Chemotherapy as a Predictor of Overall Survival. Proc Amer Soc Clin Oncol 2007 22. Srinivas S, Roigas J, Gillessen S, Harmenberg U, De Mulder PH, Fountzilas G, Vogelzang N, Peschel C, Flodgren B, Escudier B. Continuous daily administration of sunitinib in patients (pts) with cytokine-refractory metastatic renal cell carcinoma (mRCC) – updated results. Proc Amer Soc Clin Oncol 2007 23. Katznelson L, Kent K, Srinivas S. The effects of intermittent androgen deprivation therapy (ADT) and zoledronic acid administration on bone density in patients with prostate cancer. Proc Amer Soc Clin Oncol 2007 24. Stadler WM, Figlin RA, Ernstof MS, Curti B, Pendergrass K, Srinivas S, Canfield V, Weissman C, Poulin-Costello M, Bukowski R, and on behalf of the ARCCS Investigators. The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) expanded 12 access trial: safety and efficacy in patients (pts) with non-clear cell (NCC) renal cell carcinoma (RCC). Proc Amer Soc Clin Oncol 2007 25. Colocci N, King C, Brooks J, Gill H, Presti J, Srinivas S. Adjuvant doxetaxel chemotherapy with abbreviated hormonal therapy in patients with high-risk prostate cancer. Proc Amer Soc Clin Oncol 2007 26. Ross R, Stein M, Sarantopolous J, Eisenberg P, Logan T, Srinivas S, Rosenberg J, Vaishampayan U. A phase 2 study of the c-Met RTK inhibitor XL880 in patients (pts) with papillary renal-cell carcinoma (PRC). Proc Amer Soc Clin Oncol 2007 27. Vaughn D, Srinivas S, Stadler W, Pili R, Petrylak D, Sternberg C, Smith D, Nason S, De Wit E, George C. Phase II study of single-agent vinflunine in platinumrefractory advanced/metastatic transitional cell carcinoma (TCC) of the urothelium.; Proc Amer Soc Oncol 2007 28. Srinivas S, Harshman LC, Feldman DR. A phase II trial of calcitrol and naproxen in recurrent prostate cancer. Proc Amer Soc Oncol 2008 29. Harshman LC, Kuo CJ, Wong , Vogelzang NJ, Srinivas S. Bevacizumab-associated erythrocytosis in advanced renal cell carcinoma (RCC) Proc Amer Soc Oncol 2008 30. Telli ML, Witteles RM, Fisher GA, Srinivas S. Cardiotoxicity associated with the cancer therapeutic agent sunitinib malate. Proc Amer Soc Oncol 2008 31. Harshman LC, Bepler G, Zheng Z, Higgins JP, Allen GI, Tibshirani R, Srinivas S. Correlation of RRM1 expression in muscle invasive locally advanced urothelial cancer with age. J Clin Oncol 27, 2009 (suppl; abstr e16021 32. Witteles RM, Harshman LC, Telli M, Srinivas S. Prospective cardiotoxicity screening during tyrosine kinase inhibitor therapy for renal cell carcinoma: An institutional experience. J Clin Oncol 27, 2009 (suppl; abstr e16003 33. Harshman LC, Telli ML, Witteles RM, Srinivas S. Low incidence of symptomatic cardiotoxicity associated with sorafenib in patients with metastatic renal cell carcinoma (mRCC): An institutional experience 34. Harshman LC, McMillan A, Srinivas S. Treatment of refractory metastatic renal cell carcinoma (RCC) with bevacizumab and RAD001. Clin Oncol 28:15s, 2010 (suppl; abstr TPS236 35. Harshman LC, Yu R, Gill HS, Srinivas S, Chung BI. Surgical complications associated with presurgical tyrosine kinase inhibition for advanced renal cell carcinoma (RCC) 2010 Genitourinary Cancers Symposium Abstract No: 404 13 36. Patel P, R. Balise R, Srinivas S. Predictive value for relapse of variation in alphafetoprotein (AFP) levels in patients who are in remission from germ cell cancer. J Clin Oncol 28, 2010 (suppl; abstr e15119 37. Alva AS, Agarwal N, Siefker-Radtke AO, Roth BJ, Smith DC, Daignault S, Srinivas S, Bradley DA, Hussain M. Targeting epidermal growth factor receptor (EGFR) in urothelial cancer (UC): A phase II randomized trial of cisplatin (C) with gemcitabine (G) with or without cetuximab. J Clin Oncol 28:15s, 2010 (suppl; abstr TPS239) 38. Srinivas S, Harshman LC, Feldman D. Effect of fulvestrant on PSA doubling time in patients with castration-resistant prostate cancer (CRPC).J Clin Oncol 28, 2010 (suppl; abstr e15112) Ongoing Research Support STUDY: A phase II study of pazopanib in combination with weekly paclitaxel in refractory urothelial cancer. 04/06/10 - 04/30/12 ROLE: PI TYPE OF STUDY: Investigator Initiated SPONSOR: GlaxoSmithKline PLANNED NUMBER OF SUBJECTS: Stanford 33 REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: Temsirolimus, an mTor inhibitor to reverse androgen insensitivity in patients with castrate resistant prostate cancer. 05/27/09 - 05/27/12 ROLE: PI TYPE OF STUDY: Investigator Initiated SPONSOR: National Comprehensive Cancer Network PLANNED NUMBER OF SUBJECTS: Stanford 30 REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: Treatment of Refractory Metastatic Renal Cell Carcinoma with Bevacizumab and RAD0001 dates? ROLE:co- PI TYPE OF STUDY: Investigator Initiated SPONSOR: Novartis Pharmaceuticals Corp PLANNED NUMBER OF SUBJECTS: Stanford 30 REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: A Phase II Study of Sorafenib in Patients with Metastatic Renal Cell Carcinoma. ROLE: PI 07/16/07 - 07/15/11 TYPE OF STUDY: Investigator Initiated multi instituitioal trial SPONSOR: Bayer Corporation PLANNED NUMBER OF SUBJECTS: Stanford 10 Other 10 14 REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: Phase II Study of Granulocyte-macrophage Colony Stimulating Factor Plus Mitoxantrone for the treatment of Hormone Refractory Prostate Cancer. ROLE: PI? 04/25/06 - 03/31/11 TYPE OF STUDY: Investigator Initiated SPONSOR: Bayer Corporation PLANNED NUMBER OF SUBJECTS: Stanford 10 REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: Fulvestrant in Hormone Refractory Prostate Cancer ROLE: PI TYPE OF STUDY: Investigator Initiated SPONSOR: Astra Zeneca PLANNED NUMBER OF SUBJECTS: Stanford 10 REGISTRATION NUMBER AT ClinicalTrials.gov: 09/01/06 - 08/31/10 STUDY: A Phase 1b/2 Study to Assess the Safety and Efficacy in AMG102 in Combination with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer 11/18/08 - 11/30/12 ROLE: PI TYPE OF STUDY: Industry-initiated multi-institutional trial SPONSOR: Amgen PLANNED NUMBER OF SUBJECTS: Stanford 3 Other __ REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: Phase II Randomized Trial of Gemcitabine and Cisplatin with or without Cetuximab in Patients with Urothelial Carcinoma. 04/01/09 - 12/31/10 ROLE: PI TYPE OF STUDY: Industry-initiated multi-institutional trial SPONSOR: National Comprehensive Cancer Network PLANNED NUMBER OF SUBJECTS: Stanford 5 Other 60 REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: Comparison of DCE MRI and FDG PET/CT for Monitoring Targeted Therapy in Renal Cell Cancer (Quan, PI) 10/01/09 - 09/30/11 ROLE: Co-PI TYPE OF STUDY: Investigator Initiated single institution trial SPONSOR: National Institutes of Health PLANNED NUMBER OF SUBJECTS: Stanford 20 REGISTRATION NUMBER AT ClinicalTrials.gov: 15 STUDY: A Phase Ib, Open-label, Dose-finding Study to Evaluate the Safety of AV-951 in Combination with Temsirolimus in Subjects with Metastatic Renal Cell Carcinoma. ROLE: PI 08/26/08 - 07/31/11 TYPE OF STUDY: Industry-initiated multi-institutional trial SPONSOR: Aveo Pharmaceuticals, Inc. PLANNED NUMBER OF SUBJECTS: Stanford 6 Other __ REGISTRATION NUMBER AT ClinicalTrials.gov: STUDY: A Phase 2 Study of the c Met RTK Inhibitor XL880 in Subjects with Papillary Renal-cell Carcinoma (PRC). 10/01/06 - 12/31/10 ROLE: PI TYPE OF STUDY: Industry-initiated multi-institutional trial SPONSOR: GlaxoSmithKline PLANNED NUMBER OF SUBJECTS: Stanford 5 Other __ REGISTRATION NUMBER AT ClinicalTrials.gov: Completed Research Support Celgene, Inc., Srinivas (PI) Thalidomide in metastatic renal cell carcinoma investigator initiated 12/98-12/02 Eli Lilly, Srinivas (PI) Taxol/Gemcitabine in Bladder Cancer 5/98-5/02 Sanofi-Synthelabo, Srinivas (PI) 02/04/04-01/15/07 Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer. Celgene Corporation, Srinivas (PI) 01/20/03 to 01/31/05 A Phase II Trial Of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma. Novacea, Inc. 02/06/06 - 10/31/08 A Phase II Trial of Calcitrol and Naprosyn in Recurrent Prostate Cancer 16 Novartis Pharma AG CZOL446EUS4 09/15/03 - 06/30/09 Zoledronic Acid with Intermittent Hormonal Therapy in Patients with Prostate Cancer Genentech, Inc. AVF4304S 07/07/08 - 07/06/11 Treatment of refractory metastatic renal cell carcinoma with Bevacizumab and RAD001 Infinity Pharmaceuticals, Inc. IPI-504 04/03/08 - 04/02/10 A Phase 2, Open-label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients with Castration-resisitant Prostate Cancer Agennix, Inc., Srinivas (PI) 08/04/04 –07/31/06 A Multi-Center, Phase 2, Open Label Study of Safety and Efficacy of Oral Recombinant Human Lactoferrin (rhLF) Monotherapy in Patients with Advanced Renal Cell Carcinoma (RCC), Who Have Failed at Least One Regimen of Systemic Therapy for Renal Cell Carcinoma. This contract will fund the cost of the clinical trial. Overlap: None Abgenix, Inc., Srinivas (PI) 10/01/03-09/30/06 A Two Part, Multiple Dose Clinical Trial Evaluating the Safety and Effectiveness of Two Dose Levels of ABX-EGF in Patients with Renal Carcinoma. This contract will fund the cost of the clinical trial. Overlap: None Genentech, Inc., Srinivas (PI) 04/01/04 –03/31/06 A Phase II, Multicenter, randomized, double-blind clinical trial to evaluate the efficacy and Safety of Tarceva (Erlotinib hydrochloride) in combination with Avastin (Bevacizumab) versus Avastin alone for treatment of Metastatic renal Cell Carcinoma. This contract will fund the cost of the clinical trial. Overlap: None Astra Zeneca 10/08/08 - 09/30/10 A Phase II, Single Arm, Single Agen, Multi-centre, Adaptive 2-Stage Study to Evaluate the Efficacy, Safety and Pharmacokinetics of AZD4877 Administered Weekly in Patients with Recurrent Urothelial Cancer. Eli Lilly And Company 01/26/07 - 01/25/10 Phase 2 Trial of Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation, and (2) After First-line Cytotoxic Chemotherapy Pfizer Pharmaceuticals 06/23/05 - 06/30/09 A Phase 2 Efficacy and Safety Study of SU011248 Administered in a Continous Daily Regimen in Patients with Cytokine Refractory Metastatic Renal Cell Carcinoma Antisoma 08/05/05 - 08/04/09 An Open Label, Randomized, Phase II Study of AS1404 in Combination with Docetaxel in Patients with Hormone Refractory Metastatic Prostate Cancer Eli Lilly: 17 Phase 2 Trial of Oral Enzastaurin in Prostate Cancer Patients who have rising PSA (1) during Hormonal Manipulation, and (2) After First-line Cytotoxic Chemotherapy. 18 Mentoring Fellows and Junior Faculty: Date 2008-present 2007-2010 2006-2009 2004-2007 2003-2006 2003-2006 2003-2006 Name Priti Patel Mehrdad Mobasher Russell Pachynski Shane Dormady Natalia Colocci Brian Lu Tiffany Svahn Current Position Fellow - Oncology Genentech Postdoctoral fellow/Instructor Private Practice, CA Palto Medical Foundation Schering Plough, NJ John Muir Medical Center 19