| Inclusion Criteria: | 1) Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
2) All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >/= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >/= 10 mm when measured by spiral CT.
3) Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
4) Patients must not be eligible for a higher priority GOG protocol, if one exists. In general, this would refer to any active GOG Phase III protocol for the same patient population.
5) Patients must have a GOG Performance Status of 0, 1, or 2.
6) Recovery from effects of recent surgery, radiotherapy, or chemotherapy: Patients should be free of active infection requiring antibiotics. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted. Any other prior therapy directed at the malignant tumor, including biological, immunologic agents or radiation therapy, must be discontinued at least three weeks prior to registration
7) Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment.
8) Patients must be considered platinum resistant or refractory according to standard GOG criteria, i.e., have had a treatment-free interval following platinum of less than 6 months, have persistent disease at the completion of primary platinum-based therapy or have progressed during platinum-based therapy.
9) Patients who have NOT received prior therapy with paclitaxel-based chemotherapy MUST receive a second regimen that includes paclitaxel or docetaxel.
10) Patients must be considered paclitaxel-resistant, i.e., have had a treatment-free interval following paclitaxel of less than six months, or have progressed during paclitaxel-based therapy.
11) Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens. (Note: Optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy. Non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a Phase II trial).
12) Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction. Non-cytotoxic regimens are not cytotoxic.
13) Patients must have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Toxicity Criteria (CTCAE v3.0) grade 1. Platelets greater than or equal to 100,000/mcl, Hemoglobin >/= 9.0g/dL.
14) Patients must have adequate Renal function: creatinine less than or equal to 1.5 X institutional upper limit normal (ULN), CTCAE v3.0 grade 1.
15) Patients must have adequate Hepatic function: Bilirubin within normal limits (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1).
16) Patients must have adequate Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1.
17) Patients must have signed an approved informed consent and authorization permitting release of personal health information.
18) Patients must meet pre-entry requirements.
19) Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry.
20) Patients with reproductive potential must be practicing an effective method of birth control to avoid pregnancy for the duration of the trial.
21) PT such that international normalized ratio (INR) is </= 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT < 1.2 times control.
22) Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection. |