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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031187
• Other study ID #: SG0001-015
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2002
• Last updated: October 21, 2011
• Start date: October 2000
• Est. completion date: July 2003

Study information

• Verified date: October 2011
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00028470

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• SGN-15 (cBR96-doxorubicin immunoconjugate)

• Taxotere (docetaxel)

Locations

Country	Name	City	State
United States	Arlington Fairfax Hematology-Oncology, P.C.	Arlington	Virginia
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Broward Oncology Associates	Ft. Lauderdale	Florida
United States	Bendheim Cancer Center	Greenwich	Connecticut
United States	West Los Angeles - VA Healthcare Center	Los Angeles	California
United States	Innovative Medical Research of South Florida	Miami Shores	Florida
United States	VA Medical Center of Palo Alto	Palo Alto	California
United States	St. Joseph Mercy Oakland Hospital	Pontiac	Michigan
United States	Sharp HealthCare, Sidney Kimmel Cancer Center	San Diego	California
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

External Links

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