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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:
Novelos Therapeutics
ClinicalTrials.gov Identifier:
NCT00345540
First received: June 26, 2006
Last updated: January 8, 2009
Last verified: January 2009
History of Changes
  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
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Novelos Therapeutics:

Primary Outcome Measures:
  • Tumor response, evaluated every other 28 day cycle of carboplatin, which is about every eight weeks

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 25
Study Start Date: June 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 Drug: NOV-002
60 mg / mL / day / 20-23 Days

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Novelos Therapeutics
Massachusetts General Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Carolyn Kransner, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Carolyn Kransner, MD, Massachusetts General Hospital, Partners Healthcare
ClinicalTrials.gov Identifier: NCT00345540     History of Changes
Other Study ID Numbers: NOV002- IS21 -OC
Study First Received: June 26, 2006
Last Updated: January 8, 2009
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Novelos Therapeutics:
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013