Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable locally advanced progressive ovarian cancer that has failed first line platinum and taxane based regimen Refractory disease defined by a relapse within 1 year after completion of first line therapy Sensitive disease defined by a relapse greater than 1 year after completion of first line therapy Minimum of 1 target lesion that can be accurately measured in at least 1 dimension At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 times ULN (no greater than 5 times ULN if hepatic metastases present) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No ischemic heart disease within the past 6 months Normal 12 lead electrocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No unstable systemic disease or active uncontrolled infections No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma of the cervix No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) with nitrocamptothecin Chemotherapy: See Disease Characteristics Greater than 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy Surgery: Greater than 2 weeks since prior major surgery Other: No other concurrent anticancer agents No other concurrent investigational therapy
Sites / Locations
- Institut Jules Bordet
- Centre Jean Perrin
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
- CHU de la Timone
- CRLCC Nantes - Atlantique
- Centre Eugene Marquis
- Rabin Medical Center - Beilinson Campus
- Azienda Ospedaliera di Padova
- Hospital Universitario 12 de Octubre
- Ospedale San Giovanni
- Clinique De Genolier
- Newcastle General Hospital
- Western General Hospital