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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345540
First Posted: June 28, 2006
Last Update Posted: March 10, 2015
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.
Collaborators:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.
  Purpose
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 Intervention Phase
Ovarian Cancer Drug: NOV-002 Drug: Carboplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cellectar Biosciences, Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00345540


Locations
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
Investigators
Principal Investigator: Carolyn Kransner, MD Massachusetts General Hospital
  More Information

Responsible Party: Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00345540     History of Changes
Other Study ID Numbers: NOV002- IS21 -OC
First Submitted: June 26, 2006
First Posted: June 28, 2006
Results First Submitted: July 9, 2013
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:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents


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