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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00051584
First Posted: January 15, 2003
Last Update Posted: October 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seattle Genetics, Inc.
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051584


Locations
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.
Investigators
Study Director: Andrew Sandler, MD Seattle Genetics, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00051584     History of Changes
Obsolete Identifiers: NCT00056017
Other Study ID Numbers: SG015-0003
First Submitted: January 13, 2003
First Posted: January 15, 2003
Last Update Posted: October 24, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Immunoconjugates
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors