Gemcitabine With or Without Tipifarnib (R115777) in Treating Patients With Advanced Pancreatic Cancer
Pancreatic Neoplasms
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Stage II pancreatic cancer, Stage III pancreatic cancer, Recurrent pancreatic cancer, Adenocarcinoma of the pancreas, Stage IV pancreatic cancer
Eligibility Criteria
Inclusion Criteria: Pathological (confirmed by biopsy) diagnosis of pancreatic cancer have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1 (defined as a patient who does not have symptoms of pancreatic cancer and is fully active or who has symptoms but is able to light work) Exclusion Criteria: Have absolute neutrophil (white blood cell) count, platelet count (blood clotting factors), or results from liver function tests considered by the investigator to be significantly abnormal Newly diagnosed disease that has the potential for curative surgical resection Prior therapy with any chemotherapy, or any other systemic therapy for pancreatic cancer Have cardiovascular disease considered by the investigator to be uncontrolled or severe
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
001
002
Gemcitabine with R115777 R115777 200 mg oral twice daily at 12-hour intervals throughout the study coadministered with gemcitabine 1000 mg/m2 iv every week for the first 7 weeks followed by 1 week rest and then every 3 out of 4 weeks thereafter for up to 5 years
Gemcitabine with Placebo Placebo oral twice daily at 12-hour intervals throughout the study coadministered with gemcitabine 1000 mg/m2 iv every week for the first 7 weeks followed by 1 week rest and then every 3 out of 4 weeks thereafter for up to 5 years