Know Cancer

forgot password

Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma

Phase 2
18 Years
Not Enrolling
Prostatic Neoplasms

Thank you

Trial Information

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.

Inclusion Criteria


Patients must have pathologically confirmed prostate cancer, which is refractory to
hormone therapy. There must be evidence of advancing disease, determined by increasing
bidimensional or unidimensional measurable tumor or an increasing PSA with documented
metastatic disease.

Patients must have Lewis(Y) antigen expression documented by immunohistochemistry on
archived or fresh tumor specimen.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Andrew Sandler, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2000

Completion Date:

July 2003

Related Keywords:

  • Prostatic Neoplasms
  • Prostate
  • Lewis Blood-Group System
  • Antibodies, Monoclonal
  • Antigens, Neoplasm
  • Antineoplastic Agents
  • Neoplasms
  • Prostatic Neoplasms



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