R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
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)
Sites / Locations
- Fox Chase Cancer Center
- University of Texas - MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive oral R115777 twice daily for 21 consecutive days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.