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

• Status: Terminated
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies, Monoclonal; Doxorubicin; Gemcitabine; Immunoconjugates; Liposomal doxorubicin

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)