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

Ovarian Cancer Clinical Trial

Official title:

Phase 2 Trial of NOV-002 With Carboplatin in Women With Recurrent and Platinum Resistant Tumors of Mullerian Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345540
• Other study ID #: NOV002- IS21 -OC
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2006
• Last updated: February 25, 2015
• Start date: July 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2009
• Source: Cellectar Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• NOV-002
60 mg / mL / day / 20-23 Days
• Carboplatin
AUC 5 following IV bolus administration of NOV-002

Locations

Country	Name	City	State
United States	Dana Farber Cancer/Partners Cancer Care	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Cellectar Biosciences, Inc.	Dana-Farber Cancer Institute, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		At treatment completion (8 weeks) and monthly until disease progression	No
Secondary	Safety of NOV-002 and Carboplatin		Duration of trial and through 30-day follow-up period after final treatment	No
Secondary	Progression Free Survival (PFS)		From time of treatment start to time of disease progression	No