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

• ClinicalTrials.gov Identifier: NCT00345540
• Recruitment Status: Completed
• First Posted: June 28, 2006
• Results First Posted: March 10, 2015
• Last Update Posted: March 10, 2015
• Sponsor: Cellectar Biosciences, Inc.
• Collaborators: Massachusetts General Hospital; Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Cellectar Biosciences, Inc.

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: NOV002- IS21 -OC
• First Posted: June 28, 2006
• 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; Carcinoma, Ovarian Epithelial; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carboplatin; Antineoplastic Agents