Trial Information

Phase III Randomized Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) Versus 5-Fluorouracil (5-FU) in Pancreatic Cancer Patients That Have Progressive Disease Following Gemcitabine HCl Treatment

OBJECTIVES: I. Compare survival of patients with recurrent or refractory pancreatic cancer
after treatment with nitrocamptothecin versus fluorouracil. II. Compare the clinical benefit
and objective response rate to these treatment regimens in these patients. III. Compare and
evaluate time to treatment failure in these patients with these treatment regimens. IV.
Compare the toxicities of these treatment regimens in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one
of two treatment arms. Arm I: Patients receive nitrocamptothecin orally on days 1-5. Arm II:
Patients receive fluorouracil IV over 30 minutes on day 1. Treatment repeats weekly for 8
courses in the absence of disease progression or unacceptable toxicity. Patients with tumor
regression or stabilization may receive additional courses of treatment. Patients with
disease progression or unacceptable toxicity may crossover to the alternate treatment arm.
Patients are followed every 3 months for one year.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
study within 15 months.