Clinical trial NCT00345540: Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer
Official title: Phase 2 Trial of NOV-002 With Carboplatin in Women With Recurrent and Platinum Resistant Tumors of Mullerian Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Platinum Resistant Tumors of Ovarian Origin
Lead sponsor: Cellectar Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Dana-Farber Cancer Institute
First posted: 2006-06-28
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Response Rate
timeFrame: At treatment completion (8 weeks) and monthly until disease progression
Secondary outcomes:
measure: Safety of NOV-002 and Carboplatin
timeFrame: Duration of trial and through 30-day follow-up period after final treatment
measure: Progression Free Survival (PFS)
timeFrame: From time of treatment start to time of disease progression
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer/Partners Cancer Care
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Carolyn Kransner, MD
role: PRINCIPAL_INVESTIGATOR
References: