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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Gemcitabine; Lonafarnib

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