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

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

This study has been terminated.

Sponsored by:	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

MedlinePlus related topics:

Cancer Ovarian Cancer

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride Gemcitabine hydrochloride Gemcitabine BMS 182248

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Estimated Enrollment:

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

Study ID Numbers:	SG015-0003
First Received:	January 13, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00051584
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Ovarian Diseases

Doxorubicin

Antibodies, Monoclonal

Genital Diseases, Female

Antibodies

Endocrinopathy

Gemcitabine

Immunoconjugates

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antibiotics, Antineoplastic

Immunosuppressive Agents

Antiviral Agents

Pharmacologic Actions

Adnexal Diseases

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2008