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

October 21, 2011 updated by: Seagen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Andrew Sandler, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

February 27, 2002

First Submitted That Met QC Criteria

February 27, 2002

First Posted (Estimate)

February 28, 2002

Study Record Updates

Last Update Posted (Estimate)

October 24, 2011

Last Update Submitted That Met QC Criteria

October 21, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG0001-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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