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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Arizona Cancer Center
Tucson, Arizona, United States
Sharp Healthcare
San Diego, California, United States
California Hematology Oncology Medical Group
Torrance, California, United States
Mountain States Tumor Institute
Boise, Idaho, United States
Arlington Fairfax Hematology Oncology
Arlington, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
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