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

NCT ID: NCT00051584

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2003-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SGN-15 (cBR96-Doxorubicin Immunoconjugate)

Intervention Type DRUG

Gemzar (Gemcitabine)

Intervention Type DRUG

Eligibility Criteria

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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

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Andrew Sandler, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Sharp Healthcare

San Diego, California, United States

Site Status

California Hematology Oncology Medical Group

Torrance, California, United States

Site Status

Mountain States Tumor Institute

Boise, Idaho, United States

Site Status

Arlington Fairfax Hematology Oncology

Arlington, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SG015-0003

Identifier Type: -

Identifier Source: org_study_id

NCT00056017

Identifier Type: -

Identifier Source: nct_alias