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

This study has been terminated.

First Received on January 13, 2003. Last Updated on October 21, 2011 History of Changes

Sponsor:	Seattle Genetics, Inc.
Information provided by:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00051584

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 II

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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Gemcitabine Gemcitabine hydrochloride BMS 182248

U.S. FDA Resources

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

Estimated Enrollment:	60
Study Completion Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:

Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Gemcitabine
Immunoconjugates
Antibodies, Monoclonal

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012