Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006026
• Other study ID #: EORTC-16996U
• Secondary ID: EORTC-16996U
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: September 20, 2012
• Start date: May 2000

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urethral Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• rubitecan

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg	Leuven
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Henri Becquerel	Rouen
Israel	Rambam Medical Center	Haifa
Italy	Azienda Ospedaliera di Padova	Padova (Padua)
Netherlands	Rotterdam Cancer Institute	Rotterdam
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Clinique De Genolier	Genolier

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Israel,  Italy,  Netherlands,  Spain,  Switzerland,