Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Pancreas
Eligibility Criteria
Inclusion Criteria: Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed No metastases in major viscera No peritoneal seeding or ascites Biliary or gastroduodenal obstruction must have drainage before starting study therapy Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum) Performance status - Zubrod 0-1 Granulocyte count at least 1,800/mm^3 Platelet count at least 100,000/mm^3 ALT less than 3 times upper limit of normal Bilirubin less than 2.0 mg/dL Creatinine less than 3.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder No significant infection or other medical condition that would preclude study No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer No other concurrent cytotoxic agents See Disease Characteristics No prior radiotherapy to the planned field No other concurrent radiotherapy See Disease Characteristics No other concurrent investigational agents
Sites / Locations
- Radiation Therapy Oncology Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (radiation therapy, paclitaxel, gemcitabine)
Arm II (radiation therapy, tipifarnib)
Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days.