Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
|Pancreatic Cancer||Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride Radiation: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial Of Induction Gemcitabine/CPT-11 Followed By Twice-Weekly Infusion Gemcitabine And Concurrent External Beam Radiation For The Treatment Of Locally Advanced Pancreatic Cancer|
|Actual Study Start Date:||November 2001|
|Study Completion Date:||August 29, 2003|
|Primary Completion Date:||August 29, 2003 (Final data collection date for primary outcome measure)|
- Determine the time to progression, local control, and survival of patients with locally advanced, unresectable pancreatic cancer treated with induction gemcitabine and irinotecan followed by gemcitabine and concurrent radiotherapy.
OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent radiotherapy 5 days a week for 5.5 weeks.
Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025168
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center, UNC|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Southeastern Medical Oncology Center|
|Goldsboro, North Carolina, United States, 27534|
|East Carolina University School of Medicine|
|Greenville, North Carolina, United States, 27858-4354|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Greenville Hospital System|
|Greenville, South Carolina, United States, 29605|
|Spartanburg Regional Healthcare System|
|Spartanburg, South Carolina, United States, 29303|
|Study Chair:||Arthur William Blackstock, MD||Wake Forest University Health Sciences|