Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin.

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

Details

• Lead Sponsor: Cellectar Biosciences, Inc.
• Collaborators: Dana-Farber Cancer Institute; Massachusetts General Hospital
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer

• ECOG 0-1

• Platinum resistant or refractory disease defined as progressive disease within 6 months of completing or while receiving their last platinum containing regimen

• Measurable disease

Exclusion Criteria:

• History of other malignancies within 2 years except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental stage I endometrial cancer, basal or squamous cell skin cancer

• Major surgery within 2 weeks of study entry

• History of anaphylactic shock with prior platinum chemotherapy

• Known history of central nervous system (CNS) metastases unless subject has had treatment with surgery or radiation therapy and is neurologically stable

• Treatment with more than 3 lines of chemotherapy

• Chronic use of systemic corticosteroids