Status:
COMPLETED
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Lead Sponsor:
Cellectar Biosciences, Inc.
Collaborating Sponsors:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer. Platinum containing drugs such as carboplatin are the standard t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00345540
Start Date
July 1 2006
End Date
June 1 2008
Last Update
March 10 2015
Active Locations (2)
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1
Dana Farber Cancer/Partners Cancer Care
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115