A Randomized Phase II Trial of Weekly Gemcitabine, Paclitaxel and External Irradiation (50.4 GY) Followed by the Farnesyl Transferase Inhibitor R115777 (NSC #702818) for Locally Advanced Pancreatic Cancer
I. Compare the 1-year survival rate in patients with locally advanced pancreatic cancer
treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib.
II. Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in
III. Determine the feasibility and toxicity of prolonged administration of tipifarnib after
chemoradiotherapy in these patients.
IV. Determine whether tipifarnib administered after chemoradiotherapy can increase
progression-free and overall survival in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
weight loss in the preceding 6 months (more than 10% vs 10% or less) and tumor dimension (at
least 5 cm vs less than 5 cm). Patients are randomized to 1 of 2 treatment arms.
Arm I: 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.
Arm II: 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.
Treatment continues every 28 days in the absence of disease progression or unacceptable
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Calculated along with associated 95% confidence intervals.
Radiation Therapy Oncology Group
United States: Food and Drug Administration
|Radiation Therapy Oncology Group||Philadelphia, Pennsylvania 19107|