Ovarian Neoplasms
Conditions
Brief 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.
Interventions
Sponsors
Seagen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Countries
United States
Outcome results
None listed