A Phase II Pilot Study of Multi-Agent Neo-Adjuvant Chemoradiation in Patients With Locally Advanced Pancreatic Adenocarcinoma
- Determine the effect of neoadjuvant chemoradiotherapy and interferon alfa on converting
patients with locally advanced unresectable adenocarcinoma of the pancreas to
- Determine the rate and severity of early and late toxic effects of these regimens in
- Improve surgical morbidity profile and overall survival of patients who undergo
- Determine overall and progression-free survival of patients treated with this regimen.
OUTLINE: This is an pilot, single center study.
- Part 1 (neoadjuvant therapy): Patients receive fluorouracil IV continuously over 24
hours on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and
interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29,
31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26,
29-33, and 36-38. Patients then undergo restaging. Patients with resectable disease
undergo surgery, and 4-10 weeks later, proceed to part 2. Patients with unresectable
disease proceed directly to part 2, 4 weeks after completion of neoadjuvant therapy.
- Part 2 (chemotherapy): Patients receive fluorouracil IV on days 1, 8, 15, 22, 29, and
36. Treatment repeats every 56 days for up to 2 courses in the absence of disease
progression or unacceptable toxicity. Patients with unresectable disease undergo
restaging after each course of fluorouracil. If the tumor subsequently becomes
resectable, patients then undergo surgery.
After completion of study treatment, patients are followed periodically for 5 years and then
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients in Whom Tumor Was Resectable
Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.
Up to 5 Years or Until Disease Progression
Edward W. Greeno, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|