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

European Organisation for Research and Treatment of Cancer - EORTC34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

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

Interventions

gemcitabine hydrochlorideDRUG

lonafarnibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Nijmegen

Nijmegen, Netherlands

Data from ClinicalTrials.gov

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