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

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Information provided by:
Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00345540
First received: June 26, 2006
Last updated: January 8, 2009
Last verified: January 2009

June 26, 2006
January 8, 2009
June 2006
May 2008   (final data collection date for primary outcome measure)
Tumor response, evaluated every other 28 day cycle of carboplatin, which is about every eight weeks
Tumor response, evaluated every other 28 day cycle of carboplatin - which is about every eight weeks
Complete list of historical versions of study NCT00345540 on ClinicalTrials.gov Archive Site
Safety
Same as current
Not Provided
Not Provided
 
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-Resistant Ovarian Cancer
Phase 2 Trial of NOV-002 With Carboplatin in Women With Recurrent and Platinum Resistant Tumors of Mullerian Origin

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.

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 treatment for ovarian cancer, and are effective for many women. However, in many women the cancer eventually stops responding to the chemotherapy (becomes resistant).

The active part of NOV-002 is a substance made by the body that is involved in many chemical reactions in cells. NOV-002 does not directly kill cancer cells, but previous research has shown that it may make cancer cells more likely to be killed by chemotherapy drugs. Specifically, it may help platinum chemotherapy kill cancer that has become resistant to platinum chemotherapy. Previous trials have also shown that patients receiving NOV-002 in addition to carboplatin may have tolerated chemotherapy better than those who received chemotherapy alone. NOV-002 has been used in other research studies on various types of cancer. It is approved for use in Russia. It is not approved by the US Food and Drug Administration (FDA) for use outside of research studies.

In this research study, the investigators are looking to see if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has stopped responding to carboplatin chemotherapy alone.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: NOV-002
60 mg / mL / day / 20-23 Days
Experimental: NOV-002
Intervention: Drug: NOV-002
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2008
May 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00345540
NOV002- IS21 -OC
No
Carolyn Kransner, MD, Massachusetts General Hospital, Partners Healthcare
Cellectar Biosciences, Inc.
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
Principal Investigator: Carolyn Kransner, MD Massachusetts General Hospital
Cellectar Biosciences, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP