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Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract
This study is ongoing, but not recruiting participants.
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006026
  Purpose

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 Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: rubitecan
Phase II

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Camptothecin Rubitecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced/Metastatic Urothelial Tract Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2000
Detailed Description:

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006026

Locations
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, France, 21079
Centre Henri Becquerel
Rouen, France, 76038
Centre Jean Perrin
Clermont-Ferrand, France, 63011
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Israel
Rambam Medical Center
Haifa, Israel, 31096
Italy
Azienda Ospedaliera di Padova
Padova (Padua), Italy, 35128
Netherlands
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Switzerland
Clinique De Genolier
Genolier, Switzerland, Ch-1272
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Pierre Fumoleau, MD, PhD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000068038, EORTC-16996U
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006026  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
squamous cell carcinoma of the bladder
adenocarcinoma of the bladder
recurrent urethral cancer
anterior urethral cancer
posterior urethral cancer
urethral cancer associated with invasive bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter

Study placed in the following topic categories:
Squamous cell carcinoma
Ureteral Diseases
Urogenital Neoplasms
9-nitrocamptothecin
Urologic Neoplasms
Carcinoma, Transitional Cell
Kidney cancer
Urologic Diseases
Kidney Neoplasms
Neoplasm Metastasis
Carcinoma, squamous cell
Kidney Diseases
Bladder neoplasm
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Renal cancer
Transitional cell carcinoma
Camptothecin
Recurrence
Carcinoma
Epidermoid carcinoma
Urethral cancer
Urethral Neoplasms
Adenocarcinoma
Carcinoma, Squamous Cell
Ureteral Neoplasms
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Urethral Diseases

ClinicalTrials.gov processed this record on January 16, 2009