A Phase II, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
1. Histologically or cytologically confirmed recurrent epithelial ovarian or primary
peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO
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
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.
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.