Overview

Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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 metastatic cancer of the urinary tract.
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 confirmed metastatic or unresectable primary
carcinoma of the urinary tract including bladder, ureter, and renal pelvis Transitional
cell carcinoma OR Mixed cell carcinoma OR Squamous cell carcinoma OR Adenocarcinoma
Measurable disease 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/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline
phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN in
case of hepatic metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular:
Normal cardiac function No ischemic disease in past 6 months Other: Not pregnant or nursing
Fertile patients must use effective contraception No other prior malignancies except cone
biopsied carcinoma of the cervix or adequately treated basal or squamous cell skin
carcinoma No concurrent unstable systemic disease or active uncontrolled infection No
psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Must have received
1 prior chemotherapy regimen for advanced or metastatic disease At least 4 weeks since
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since
prior radiotherapy Surgery: At least 14 days since prior major surgery Other: No other
concurrent anticancer agents No other concurrent investigational therapy