Clinical trial NCT00466986: Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer
Official title: A Phase II, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Keywords: recurrent
ovarian
cancer
platinum sensitive
Lead sponsor: Southeastern Gynecologic Oncology
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2007-04-27
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the combination of Abraxane and Carboplatin together will improve the chances of controlling recurrent ovarian/fallopian tube/peritoneal cancer.

Detailed description: Current best practice recommends Carboplatin combined with Taxol in the treatment of Ovarian cancer.

Taxol is paclitaxel in the solvent Cremophor-El and the solvent has been associated with significant side effects e.g. anaphylaxis and hypersensitivity. this requires the routine use of premedication with antihistamines and steroids.

Abraxane by contrast is Cremophor-El free and is protein bound. This has 2 advantages over Taxol.

1. No need for routine premedications
2. Increased drug entry into cells facilitating greater potential for anti-tumor activity.

Schedule: Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed recurrent epithelial ovarian or primary peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO Classification.
2. Measurable Disease by RECIST Criteria (defined by the presence of at least 1 measurable lesion (see Section 7.7.1 for definition of measurable lesions) or elevated CA-125 in the absence of measurable disease. A pre-treatment sample of CA-125 will be collected within 2 weeks before treatment is started. A pre-treatment sample of CA-125 should be at least twice the upper limit of normal.
3. Patients must have disease recurrence 6 months or more after completion of front-line platinum and paclitaxel-containing regimen. Duration of response from prior therapy and prior consolidation therapy will be documented in case report forms for descriptive analysis.
4. Patients must have received at least 3 cycles of a front-line taxane and platinum-containing regimen prior to entry on this study.
5. Patients must have a documented complete clinical response on front-line therapy.
6. Patients must be disease-free from prior malignancies for more than 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
7. Life expectancy of \> 6 months.
8. ECOG (Zubrod) performance status 0-2.
9. Age \>18 years.
10. Patient has the following blood counts at Baseline:

    * ANC \> 1.5 x 10-9 c/L;
    * platelets \> 100 x 10-9 c/L;
    * Hgb \> 9 g/dL.
11. Patient has the following blood chemistry levels at Baseline:

    * AST (SGOT), ALT (SGPT) \< 1.5x upper limit of normal range (ULN);
    * total bilirubin NORMAL;
    * alkaline phosphatase \< 2.5x ULN
    * creatinine \< 1.5 mg/dL.
12. Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

1. Patients who have received more than one prior chemotherapy regimen.
2. Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month.
3. Patient has pre-existing peripheral neuropathy of grade \>/= 2 (per National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events version 3.0 \[CTCAE\].
4. Patients receiving concurrent or intervening other chemotherapy, hormonal (for treatment of ovarian carcinoma), immunotherapy, or radiotherapy.
5. Patient has a clinically significant concurrent illness.
6. Patient is, in the Investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
7. Patient has a history of allergy or hypersensitivity to the study drug.
8. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
9. Patient is enrolled in any other clinical protocol or investigational trial.
10. Patients of childbearing potential, not practicing adequate contraception.

Primary outcomes:
measure: Response Rate
timeFrame: 5 years
Secondary outcomes:
measure: Time to Response
timeFrame: 5 years
measure: Duration of Response
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
measure: Progression Free Survival
timeFrame: 5 years
measure: Safety
timeFrame: 5 years
measure: Tolerability
timeFrame: 5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Southeastern Gynecologic Oncology
state: Georgia
Study officials:
affiliation: Southeastern Gynecologic Oncology
name: Benidict B Benigno, MD
role: PRINCIPAL_INVESTIGATOR
References: