Chemotherapy, Interferon Alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00068575|
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : February 14, 2012
Last Update Posted : February 15, 2012
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and interferon alfa with radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and interferon alfa together with radiation therapy works in treating patients who have undergone surgery for stage I, stage II, or stage III pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: Recombinant Interferon Alfa Drug: Cisplatin Drug: Fluorouracil Radiation: Radiation Therapy||Phase 2|
- Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy.
- Determine the toxic effects of this regimen in these patients.
- Determine the disease-specific, biochemical failure-free, and symptom/treatment-free survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Chemoradiotherapy: Patients receive fluorouracil intravenous (IV) continuously and interferon alfa subcutaneously (SQ) 3 times per week (total of 17 doses) on days 1-19 and 29-45 and cisplatin IV over 6 hours on days 1, 8, 15, 29, 36 and 43. Patients also undergo concurrent radiotherapy once daily, 5 days a week in weeks 1-3 and 5-7 (28 fractions).
- Post-chemoradiotherapy fluorouracil: Patients receive fluorouracil IV continuously on days 71-108 and 127-168.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Pancreaticoduodenectomy Plus Postoperative Cisplatin, Interferon Alfa-2b, and 5-FU Combined With Radiation Treatment for Patients With Resected Pancreatic Adenocarcinoma|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Postoperative Chemoradiation Regimen
Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
Biological: Recombinant Interferon Alfa
3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses.
30 mg/m^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy.
175 mg/m^2/day continuous infusion over 6 1/2 weeks for total 3 courses: Days 1-19 and 29-45, Days 71-108 and Days 127-168.
Radiation: Radiation Therapy
External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.
- Median Overall Survival (OS) [ Time Frame: Participants followed till disease progression or death (approximately 6 years) ]Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068575
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Peter W. Pisters, MD||M.D. Anderson Cancer Center|