At a glance
ClinicalIndex Comparison Record- ✓Biopsy-proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process, AJCC Stage I-III
- ✓Protocol treatment must begin within 12 weeks of surgery
- ✓Postoperative CT scan without evidence of radiographically definable residual primary/metastatic disease or clinically significant post-surgical changes
- ✓Staging studies completed within three weeks ±3 days of protocol registration
- ✕Residual metastatic or incompletely resected local disease
- ✕Positive peritoneal cytology for adenocarcinoma at laparotomy or laparoscopic assessment
- ✕History of hypersensitivity to interferon alfa-2b
- ✕Significant cardiovascular disease (unstable angina, congestive heart failure)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Recombinant Interferon Alfa, Cisplatin, and 2 other interventions for Pancreatic Cancer. Completed, enrolled 29 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
External beam radiation on days 1-19 and days 29-45, 9 day treatment break on day 20.