Ovarian Cancer
Conditions
Keywords
Platinum Resistant Tumors of Ovarian Origin
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.
Interventions
DRUGNOV-002
60 mg / mL / day / 20-23 Days
DRUGCarboplatin
AUC 5 following IV bolus administration of NOV-002
Sponsors
Massachusetts General Hospital
Dana-Farber Cancer Institute
Cellectar Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | At treatment completion (8 weeks) and monthly until disease progression |
Secondary
| Measure | Time frame |
|---|---|
| Safety of NOV-002 and Carboplatin | Duration of trial and through 30-day follow-up period after final treatment |
| Progression Free Survival (PFS) | From time of treatment start to time of disease progression |
Countries
United States
Participant flow
Recruitment details
The trials opened to enrollment July 2006 and the study was closed out June 2008. Recruitment locations were: Dana Farber Cancer/Partners Cancer Care, Boston, MA and Massachusetts General Hospital, Boston, MA
Pre-assignment details
Patients were platinum refractory/resistant, with measurable disease and ≤ 3 prior lines.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | NOV-002 Plus Carboplatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 9 / 15 |
Outcome results
Primary
Response Rate
Time frame: At treatment completion (8 weeks) and monthly until disease progression
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOV-002 Plus Carboplatin | Response Rate | Complete Response (CR) | 0 Participants |
| NOV-002 Plus Carboplatin | Response Rate | Partial Response (PR) | 1 Participants |
| NOV-002 Plus Carboplatin | Response Rate | Stable Disease (SD) | 8 Participants |
| NOV-002 Plus Carboplatin | Response Rate | Progressive Disease (PD) | 6 Participants |
Secondary
Progression Free Survival (PFS)
Time frame: From time of treatment start to time of disease progression
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NOV-002 Plus Carboplatin | Progression Free Survival (PFS) | 19.4 Weeks |
Secondary
Safety of NOV-002 and Carboplatin
Time frame: Duration of trial and through 30-day follow-up period after final treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOV-002 Plus Carboplatin | Safety of NOV-002 and Carboplatin | CTC Grade 4 Adverse Events | 0 Adverse Events |
| NOV-002 Plus Carboplatin | Safety of NOV-002 and Carboplatin | CTC Grade 3 Adverse Events | 8 Adverse Events |
| NOV-002 Plus Carboplatin | Safety of NOV-002 and Carboplatin | CTC Grade 3 Related Adverse Events | 0 Adverse Events |