Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IIIA Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Recurrent Ovarian Epithelial Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal cancer: Advanced disease Meets at least 1 of the following criteria: Measurable disease; Evaluable disease plus CA 125 >= 2 times post-treatment nadir Treated with 1, and only 1, prior platin-containing chemotherapy regimen (e.g., paclitaxel or carboplatin-based) for ovarian epithelial or primary peritoneal cancer Prior treatment with the same regimen at first relapse allowed; No more than 3 total chemotherapy regimens allowed provided exactly 1 has been platin-containing; Must also have platin-resistant disease as defined for Group 1; Rechallenge with a single regimen upon progression after a hiatus from therapy counts as a single regimen Group 1, meeting 1 of the following criteria: Patients who relapse during or < 6 months after completion of post-debulking chemotherapy; "Platinum sensitive" patients in second relapse after having been treated/rechallenged with their initial regimen upon first relapse Group 2 (Closed to accrual as of 3/10/06): Patients who relapse >= 6 months after completion of post-debulking chemotherapy and are not retreated with the same or a different regimen No CNS metastases Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count >= 1,500/mm3; Platelet count >= 100,000/mm3; Hemoglobin >= 10 g/dL (Note: May be supported with transfusion, epoetin alfa, or darbepoetin alfa) Hepatic: AST =< 2.5 times upper limit of normal (ULN); Alkaline phosphatase =< 2.5 times ULN; Bilirubin =< 1.5 times ULN Renal: Creatinine =< 1.5 times ULN Cardiovascular: No cardiac arrhythmia; No cardiac failure Not pregnant or nursing Negative pregnancy test More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) More than 3 weeks since prior radiotherapy Recovered from all prior therapy Fertile patients must use effective contraception No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix No diabetes No peripheral neuropathy >= grade 2 No baseline diarrhea (>= 4 stools/day) No uncontrolled infection No other concurrent uncontrolled serious medical condition No concurrent routine colony-stimulating factors
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1
Group 2
Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.