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Brief Title: Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
Official Title: Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma
Study ID: NCT00031187
Brief Summary: SGN-15 is being investigated for therapy of patients with prostate cancer in combination with the cytotoxic agent, Taxotere. The study is an open label, randomized phase II study for patients with documented hormone refractory prostate cancer who have not had any prior therapy with Taxotere or Novantrone. Both SGN-15 and Taxotere will be administered weekly over two 6 week courses separated by a 2 week rest period.
Detailed Description: The purpose of this study is to evaluate a new class of biologic agent, the monoclonal antibody (mAb) drug conjugate SGN-15 (cBR96 - Doxorubicin immunoconjugate), used in combination with the taxane agent, TAXOTERE (docetaxel) as a strategy for targeting advanced stage, hormone refractory prostate carcinoma (HRPC). This is a randomized, open label, phase II study evaluating the immunoconjugate SGN-15 in combination with the taxane TAXOTERE in comparison to TAXOTERE alone in patients with HRPC. Based on a previous phase I study of the SGN-15/TAXOTERE combination, the weekly dose of SGN-15 will be 200 mg/m2 and the weekly dose of TAXOTERE will be 35 mg/m2. The schedule of administration for both agents will be weekly, with SGN-15 administered prior to the TAXOTERE in the patients treated with the combination. A single course of therapy will be defined as 6 weekly doses followed by a 2 week rest period for a total of 8 weeks. The study will perform an interim analysis of the data after 80 patients have completed two courses. Patients should be treated for a minimum of 2 courses of therapy. Additionally, for patients who remain eligible and have experienced tolerable levels of drug toxicity, repeat dosing with subsequent cycles is possible. Patients will be removed from study if there is evidence of tumor progression or intolerable toxicity. Follow-up assessments include adverse event reporting, clinical laboratory studies, and quality of life (QOL) assessment using a validated QOL instrument.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Arizona Cancer Center, Tucson, Arizona, United States
Highlands Oncology Group, Springdale, Arkansas, United States
West Los Angeles - VA Healthcare Center, Los Angeles, California, United States
VA Medical Center of Palo Alto, Palo Alto, California, United States
Sharp HealthCare, Sidney Kimmel Cancer Center, San Diego, California, United States
Bendheim Cancer Center, Greenwich, Connecticut, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Broward Oncology Associates, Ft. Lauderdale, Florida, United States
Innovative Medical Research of South Florida, Miami Shores, Florida, United States
St. Joseph Mercy Oakland Hospital, Pontiac, Michigan, United States
Arlington Fairfax Hematology-Oncology, P.C., Arlington, Virginia, United States
Name: Andrew Sandler, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR