Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer

This study has been terminated.
Information provided by:
Seattle Genetics, Inc. Identifier:
First received: January 13, 2003
Last updated: October 21, 2011
Last verified: October 2011
This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.

Condition Intervention Phase
Ovarian Neoplasms
Drug: SGN-15 (cBR96-Doxorubicin Immunoconjugate)
Drug: Gemzar (Gemcitabine)
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: A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer

Resource links provided by NLM:

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

Estimated Enrollment: 60
Study Completion Date: May 2003

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

Brief Overview of Inclusion Criteria:

  • Patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease
  • Patients must have > 20% Lewis-y antigen expression documented by immunohistochemistry
  • LVEF > 50% by echo or MUGA
  • Must be platinum resistant as defined by:

    • Progression while on initial platinum therapy or
    • Progression while on retreatment with initial platinum regimen or
    • Relapse < 6 months after initial therapy

Brief Overview of Exclusion Criteria:

  • Patients who have had prior therapy with Gemzar®
  • Cumulative anthracycline exposure > 300 mg/m2
  • More than three prior chemotherapy regimens for ovarian cancer (Retreatment with Taxane/Platinum after initial combination is considered only one regimen)
  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 identifier: NCT00051584

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Sharp Healthcare
San Diego, California, United States, 92123
California Hematology Oncology Medical Group
Torrance, California, United States, 90505
United States, Idaho
Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Virginia
Arlington Fairfax Hematology Oncology
Arlington, Virginia, United States, 22205
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Seattle Genetics, Inc.
Study Director: Andrew Sandler, MD Seattle Genetics, Inc.
  More Information Identifier: NCT00051584     History of Changes
Obsolete Identifiers: NCT00056017
Other Study ID Numbers: SG015-0003 
Study First Received: January 13, 2003
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Antibodies, Monoclonal
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors processed this record on May 01, 2016