Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Rubitecan

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