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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pierre Fumoleau, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Authority:

United States: Federal Government

Study ID:

EORTC-16996U

NCT ID:

NCT00006026

Start Date:

May 2000

Completion Date:

Related Keywords:

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

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