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.

Condition	Treatment or Intervention	Phase
Bladder Cancer Kidney Cancer Urethral Cancer	Drug: nitrocamptothecin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response to nitrocamptothecin in patients with metastatic urothelial tract tumors. II. Determine the response rate in these patients when treated with this regimen. III. Determine the duration of objective response in these patients when treated with this regimen. IV. Characterize the toxicities of this treatment in this patient population.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
France
      Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon,  21079,  France
      Centre Henri Becquerel, Rouen,  76038,  France
      Centre Jean Perrin, Clermont-Ferrand,  63011,  France
      CRLCC Nantes - Atlantique, Nantes-Saint Herblain,  44805,  France
Israel
      Rambam Medical Center, Haifa,  31096,  Israel
Italy
      Azienda Ospedaliera di Padova, Padova (Padua),  35128,  Italy
Netherlands
      Rotterdam Cancer Institute, Rotterdam,  3075 EA,  Netherlands
Spain
      Hospital Universitario 12 de Octubre, Madrid,  28041,  Spain
Switzerland
      Clinique De Genolier, Genolier,  Ch-1272,  Switzerland
      Ospedale San Giovanni, Bellinzona,  CH-6500,  Switzerland

Study chairs or principal investigators

Pierre Fumoleau,  Study Chair,  EORTC Early Clinical Studies Group   

Study ID Numbers:  CDR0000068038; EORTC-16996U
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00006026
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08