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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.

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: NOV-002 Drug: Carboplatin Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of NOV-002 With Carboplatin in Women With Recurrent and Platinum Resistant Tumors of Mullerian Origin
Study Start Date : July 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. Response Rate [ Time Frame: At treatment completion (8 weeks) and monthly until disease progression ]

Secondary Outcome Measures :
  1. Safety of NOV-002 and Carboplatin [ Time Frame: Duration of trial and through 30-day follow-up period after final treatment ]
  2. Progression Free Survival (PFS) [ Time Frame: From time of treatment start to time of disease progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345540

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United States, Massachusetts
Dana Farber Cancer/Partners Cancer Care
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Cellectar Biosciences, Inc.
Massachusetts General Hospital
Dana-Farber Cancer Institute
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Principal Investigator: Carolyn Kransner, MD Massachusetts General Hospital

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Responsible Party: Cellectar Biosciences, Inc. Identifier: NCT00345540     History of Changes
Other Study ID Numbers: NOV002- IS21 -OC
First Posted: June 28, 2006    Key Record Dates
Results First Posted: March 10, 2015
Last Update Posted: March 10, 2015
Last Verified: January 2009

Keywords provided by Cellectar Biosciences, Inc.:
Platinum Resistant Tumors of Ovarian Origin

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents