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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345540
Recruitment Status : Completed
First Posted : June 28, 2006
Results First Posted : March 10, 2015
Last Update Posted : March 10, 2015
Massachusetts General Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.

June 26, 2006
June 28, 2006
July 9, 2013
March 10, 2015
March 10, 2015
July 2006
May 2008   (Final data collection date for primary outcome measure)
Response Rate [ Time Frame: At treatment completion (8 weeks) and monthly until disease progression ]
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 Archive Site
  • Safety of NOV-002 and Carboplatin [ Time Frame: Duration of trial and through 30-day follow-up period after final treatment ]
  • Progression Free Survival (PFS) [ Time Frame: From time of treatment start to time of disease progression ]
Not Provided
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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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: NOV-002
    60 mg / mL / day / 20-23 Days
    Other Name: Oxidized Glutathione
  • Drug: Carboplatin
    AUC 5 following IV bolus administration of NOV-002
    Other Name: Paraplatin
Experimental: NOV-002 plus Carboplatin
NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
  • Drug: NOV-002
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NOV002- IS21 -OC
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Not Provided
Cellectar Biosciences, Inc.
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