R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer

OBJECTIVES:

I. Determine the safety and effectiveness of R115777 in patients with metastatic pancreatic cancer.

II. Determine the response rate, time to progression, and 6 month survival rate of these patients with this treatment regimen.

III. Assess the pharmacokinetics of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas
• Measurable metastatic disease No prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines)

PATIENT CHARACTERISTICS:

• Age: 18 and over
• Performance status: ECOG 0-2
• WBC at least 4,000/mm3 OR granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• Bilirubin no greater than 2.0 mg/dL
• SGOT/SGPT no greater than 2 times normal
• Creatinine no greater than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after the study
• No concurrent illness or active infection which would preclude study
• No prior malignancy allowed unless disease free for the time period considered appropriate for cure of the specific cancer
• No history of allergies to imidazole compounds (e.g., fluconazole, ketoconazole, miconazole, itraconazole, clotrimazole)

PRIOR CONCURRENT THERAPY:

• No prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or thrombopoietin
• Primary neoadjuvant or adjuvant chemotherapy allowed at least 6 months prior to detection of metastatic disease
• Primary radiotherapy allowed at least 6 months prior to detection of metastatic disease
• No concurrent use of proton pump inhibitors (e.g., omeprazole)