Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.

Detailed Description
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OBJECTIVES: I. Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until disease progression. PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21 months.

Official Title
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Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium

Conditions
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Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven progressive regional or metastatic transitional cell carcinoma of the urothelium or mixed histology containing a component of transitional cell carcinoma Failure of only 1 prior chemotherapy regimen for metastatic disease or in the adjuvant or neoadjuvant setting (not containing taxane or gemcitabine) Bidimensionally measurable disease No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR SGOT less than 1.5 times ULN AND alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No American Heart Association class III or IV heart disease No uncontrolled congestive heart failure No severe cardiac arrhythmias Neurologic: No sensory neuropathy grade 3 or 4 No prior peripheral neuropathy grade 2 or worse Other: No active unresolved infection being treated with parenteral antibiotics within the past 7 days No other malignancy within the past 5 years except: Curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Clinically unsuspected, organ confined prostate cancer found during cystoprostatectomy Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy Prior intravesical BCG allowed Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, posterior urethral cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter