Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients) No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present Alkaline phosphatase no greater than 2 times ULN* SGOT no greater than 2 times ULN* NOTE: *No greater than 5 times ULN if liver metastases present Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment No myocardial infarction within the past 3 months Other: No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled infection No complete bowel obstruction or other condition that would affect GI absorption or motility No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated No other concurrent medical conditions that would preclude study No mental disease No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K) Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior camptothecin analogue No prior chemotherapy for ovarian cancer No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy other than estrogen replacement Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 30 days or 5 half-lives since any prior investigational therapy No other concurrent investigational therapy No concurrent metoclopramide or cisapride
Sites / Locations
- Rigshospitalet - Copenhagen University Hospital