SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract

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 SCH 66336 and gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating patients who have advanced cancer of the urinary tract.

Detailed Description
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OBJECTIVES: Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with advanced transitional cell carcinoma of the urinary tract. Determine the time to progression and objective response rate of this treatment regimen in these patients. Assess the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral SCH 66336 twice a day (starting on day 2 of the first course, and starting on day 1 of all subsequent courses). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 7-31 patients will be accrued for this study.

Official Title
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Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997

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: gemcitabine hydrochloride
* Drug: lonafarnib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable primary transitional cell carcinoma of the urinary tract, including bladder, ureter, and renal pelvis At least one measurable lesion 20 mm or greater by conventional techniques OR 10 mm or greater by spiral CT scan Must have received one (and only one) prior chemotherapy regimen for advanced or metastatic disease No clinical signs of brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute 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 with liver metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Normal cardiac function No ischemic heart disease within the past 6 months Normal 12 lead ECG Other: No prior gastrectomy or any gastrointestinal disease that may impair absorption of SCH 66336 No unstable systemic disease No active uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study No prior or concurrent other malignancy except cone biopsied carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No prior farnesyl protein transferase inhibitors or gemcitabine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No other concurrent anticancer agents No other concurrent investigational therapy

Ages Eligible for Study
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Minimum Age: 18 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: gemcitabine hydrochloride|nan|
|Drug: lonafarnib|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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recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma 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, recurrent transitional cell cancer of the renal pelvis and ureter