S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
- Registration Number
- NCT00005832
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R115777 R115777 300mg/dose BID, PO, Days 1-21, q 28days
- Primary Outcome Measures
Name Time Method Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777 6 months
- Secondary Outcome Measures
Name Time Method Evaluate the frequency and severity of toxicities Weekly for 8 weeks and then once every 4 weeks Assess confirmed response (complete & partial) in patients with measurable advanced adenocarcinoma of the pancreas Once every 8 weeks Time to treatment failure Once every 8 weeks until progression
Trial Locations
- Locations (14)
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States