Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Andrew Sandler, MD
Seattle Genetics, Inc.
United States: Food and Drug Administration
|Arizona Cancer Center||Tucson, Arizona 85724|
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Highlands Oncology Group||Springdale, Arkansas 72764|
|West Los Angeles - VA Healthcare Center||Los Angeles, California 90073|
|VA Medical Center of Palo Alto||Palo Alto, California 94304|
|Sharp HealthCare, Sidney Kimmel Cancer Center||San Diego, California 92121|
|Bendheim Cancer Center||Greenwich, Connecticut 06830|
|Broward Oncology Associates||Ft. Lauderdale, Florida 33308|
|Innovative Medical Research of South Florida||Miami Shores, Florida 33138|
|St. Joseph Mercy Oakland Hospital||Pontiac, Michigan 33308|
|Arlington Fairfax Hematology-Oncology, P.C.||Arlington, Virginia 22205|