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Home > "N" Clinical Trials Conditions > Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract  Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
For Condition: Bladder Cancer,Kidney Cancer,Urethral Cancer
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PierreFumoleau, Study Chair, EORTC Early Clinical Studies Group
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Ospedale San Giovanni
Bellinzona, , CH-6500
Switzerland
Rambam Medical Center
Haifa, , 31096
Israel
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Clinique De Genolier
Genolier, , Ch-1272
Switzerland
Centre Henri Becquerel
Rouen, , 76038
France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
Azienda Ospedaliera di Padova
Padova (Padua), , 35128
Italy
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Additional Information:
Study ID Numbers: CDR0000068038; EORTC-16996U
Study Start Date: May 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006026
Other Urethral Cancer Studies:
1. Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
2. Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
3. Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
4. Gene Therapy in Treating Patients With Cancer
5. Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
Related Studies:
Other Urethral Cancer Clinical Trials
Other Clinical Trials
Other Genolier Clinical Trials
Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
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