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

February 25, 2015 updated by: Cellectar Biosciences, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer/Partners Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Oxidized Glutathione
Drug: Carboplatin
AUC 5 following IV bolus administration of NOV-002
Other Names:
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: At treatment completion (8 weeks) and monthly until disease progression
At treatment completion (8 weeks) and monthly until disease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of NOV-002 and Carboplatin
Time Frame: Duration of trial and through 30-day follow-up period after final treatment
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
From time of treatment start to time of disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellectar Biosciences, Inc.

Collaborators

Massachusetts General Hospital
Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Carolyn Kransner, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOV002- IS21 -OC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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