Overview

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