Overview

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