Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
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| ClinicalTrials.gov Identifier: NCT00003175 |
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Recruitment Status :
Completed
First Posted : April 30, 2004
Last Update Posted : December 4, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer | Drug: fluorouracil | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 45 participants |
| Primary Purpose: | 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 |
| Study Start Date : | December 1997 |
| Actual Study Completion Date : | March 2009 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003175
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| Study Chair: | Peter G. Harper, MD | St. Thomas' Hospital |
| ClinicalTrials.gov Identifier: | NCT00003175 |
| Other Study ID Numbers: |
CDR0000065985 MRC-BA10 EU-97029 |
| First Posted: | April 30, 2004 Key Record Dates |
| Last Update Posted: | December 4, 2013 |
| Last Verified: | February 2010 |
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recurrent bladder cancer transitional cell carcinoma of the bladder recurrent urethral cancer recurrent transitional cell cancer of the renal pelvis and ureter |
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Urinary Bladder Neoplasms Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Urethral Diseases Kidney Diseases Ureteral Diseases Fluorouracil Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |