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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003175 |
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 fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.
Condition | Intervention | Phase |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: fluorouracil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract |
Estimated Enrollment: | 45 |
Study Start Date: | December 1997 |
OBJECTIVES: I. Determine the response rate and toxic effects of continuous fluorouracil in patients with recurrent locally advanced or metastatic transitional cell urinary tract carcinoma. II. Determine the feasibility of this treatment in this patient population.
OUTLINE: Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24 weeks. Patients are evaluated for complete and partial response at 8, 16, and 24 weeks after the start of intravenous fluorouracil. Patients experiencing disease progression or unacceptable toxic effects are removed from the study. Patients are followed monthly for 6 months post treatment.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven recurrent locally advanced or metastatic transitional cell urinary tract carcinoma that has been previously untreated with systemic chemotherapy Pelvic relapse after radiotherapy or surgery No relapse solely within a previously irradiated field Nodal or metastatic disease Lesions within the abdomen or pelvis must be assessed using CT scanning At least one site of disease must be previously unirradiated and assessable for response Bone metastases cannot be used as an indicator lesion Measurable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance Status: Not specified Life Expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Glomerular filtration rate at least 50 mL/min Creatinine clearance at least 25 mL/min
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy:
See Disease Characteristics Surgery: See Disease Characteristics
Study Chair: | Peter G. Harper, MD | St. Thomas' Hospital |
Study ID Numbers: | CDR0000065985, MRC-BA10, EU-97029 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003175 History of Changes |
Health Authority: | United States: Federal Government |
recurrent bladder cancer transitional cell carcinoma of the bladder recurrent urethral cancer recurrent transitional cell cancer of the renal pelvis and ureter |
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Renal Cancer Urologic Diseases Kidney Neoplasms Urethral Cancer Kidney Diseases Bladder Neoplasm |
Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Immunosuppressive Agents Recurrence Carcinoma Fluorouracil Urethral Neoplasms Ureteral Neoplasms Neoplasms, Glandular and Epithelial Transitional Cell Carcinoma |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses |
Urethral Diseases Kidney Diseases Neoplasms by Histologic Type Urinary Bladder Diseases Urinary Bladder Neoplasms Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Fluorouracil Urethral Neoplasms Ureteral Neoplasms Neoplasms, Glandular and Epithelial |