Phase II Trial of R115777 (NSC-702818), an Inhibitor of Farnesyl Protein Transferase, in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
I. Determine the safety and effectiveness of R115777 in patients with metastatic pancreatic
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Neal J. Meropol, MD
Fox Chase Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|