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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

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

Treatments: Drug: lonafarnib; Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00006351

EORTC-16997

EORTC-GU-16997

EORTC-PAMM-16997

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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