NCT00005832

S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• 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. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.

Detailed description

OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients. OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	R115777	300mg/dose BID, PO, Days 1-21, q 28days

Timeline

• Start date: 2000-06-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2004-04-26
• Last updated: 2015-11-17

Locations

14 sites across 1 country: United States