NCT00005871

Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil
DRUG	rubitecan

Timeline

• Start date: 1998-11-01
• First posted: 2004-05-03
• Last updated: 2013-12-04

Locations

1 site across 1 country: United States