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Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
This study has been completed.
First Received: February 27, 2002   Last Updated: June 13, 2007   History of Changes
Sponsor: Seattle Genetics, Inc.
Information provided by: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00031187
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
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
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
VA Medical Center of Palo Alto
Palo Alto, California, United States, 94304
Sharp HealthCare, Sidney Kimmel Cancer Center
San Diego, California, United States, 92121
West Los Angeles - VA Healthcare Center
Los Angeles, California, United States, 90073
United States, Connecticut
Bendheim Cancer Center
Greenwich, Connecticut, United States, 06830
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Innovative Medical Research of South Florida
Miami Shores, Florida, United States, 33138
Broward Oncology Associates
Ft. Lauderdale, Florida, United States, 33308
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

Study ID Numbers: SG0001-015
Study First Received: February 27, 2002
Last Updated: June 13, 2007
ClinicalTrials.gov Identifier: NCT00031187     History of Changes
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:
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Docetaxel
Antibodies, Monoclonal
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Immunoconjugates

ClinicalTrials.gov processed this record on November 22, 2009