Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00031187
First received: February 27, 2002
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: SGN-15 (cBR96-doxorubicin immunoconjugate)
Drug: Taxotere (docetaxel)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Estimated Enrollment: 160
Study Start Date: October 2000
Study Completion Date: July 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

BRIEF:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031187

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Highlands Oncology Group
Springdale, Arkansas, United States, 72764
United States, California
West Los Angeles - VA Healthcare Center
Los Angeles, California, United States, 90073
VA Medical Center of Palo Alto
Palo Alto, California, United States, 94304
Sharp HealthCare, Sidney Kimmel Cancer Center
San Diego, California, United States, 92121
United States, Connecticut
Bendheim Cancer Center
Greenwich, Connecticut, United States, 06830
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Broward Oncology Associates
Ft. Lauderdale, Florida, United States, 33308
Innovative Medical Research of South Florida
Miami Shores, Florida, United States, 33138
United States, Michigan
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 33308
United States, Virginia
Arlington Fairfax Hematology-Oncology, P.C.
Arlington, Virginia, United States, 22205
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Andrew Sandler, MD Seattle Genetics, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00031187     History of Changes
Obsolete Identifiers: NCT00028470
Other Study ID Numbers: SG0001-015
Study First Received: February 27, 2002
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Prostate
Lewis Blood-Group System
Antibodies, Monoclonal
Antigens, Neoplasm
Antineoplastic Agents

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Immunoconjugates
Liposomal doxorubicin
Docetaxel
Antineoplastic Agents
Doxorubicin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 28, 2014