| Inclusion Criteria: | 1) Patient has histologically or cytologically confirmed diagnosis of high-grade or intermediate-grade epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer, including serous papillary, endometrioid, mucinous, clear cell, poorly differentiated adenocarcinoma or mixed epithelial ovarian cancer.
2) Patient has recurrent platinum refractory resistant epithelial ovarian cancer following primary treatment. Considered platinum refractory or resistant according to standard GOG criteria to have had a treatment-free interval following platinum of shorter than 6 months as platinum refractory, or have progressed during platinum-based therapy or have persistent disease after at least six cycles of platinum therapy as platinum resistant.
3) Patient has measurable disease by radiological imaging techniques with documented progression within 3 months before study entry or disease that has not responded to treatment. Pleural effusions, ascites, osseous metastasis, CA125 tumor markers and lesions located in previously irradiated areas are not considered measurable.
4) Patient has at least one, but no more than six prior chemotherapy regimens. All platinum-containing regimens are counted as one.
5) Patient is at least 18 years of age.
6) Patient has an ECOG performance status of 0-2.
7) Patient is willing to comply with study procedures and follow-up examinations.
8) Patient must be informed of the investigational nature of this study and must sign and give written IRB approved informed consent in accordance with institutional guidelines.
9) If patient is of child-bearing potential, she has agreed to practice an effective method of birth control during the study and up to 6 months after the last study dose.
10) Patient has adequate liver and renal function: serum bilirubin =/<2.0 mg/dL; albumin =/> 3.0 g/dL; ALT=/<3x upper limit of normal (uln) or ALT =/<5x uln if the patient has hepatic metastasis; and serum creatinine =/<1.5 mg/dL or a calculated creatinine clearance of at least 60 ml/min.
11) Patient has adequate bone marrow reserve. ANC=/> 1,500/mm(3), Platelet count =/> 75,000/mm(3), and Hemoglobin =/> 9.0g/dL. |