Low-Dose Radiotherapy as a Chemopotentiator of Gemcitabine in Tumors of the Pancreas or Small Bowel: A Phase I Study Exploring a New Treatment Paradigm

William F. Regine, Nader Hanna, Michael C. Garofalo, Austin Doyle, Susanne Arnold, Ritesh Kataria, Jacqueline Sims, Ming Tan, Mohammed Mohiuddin

Research output: Contribution to journalArticlepeer-review

31 Scopus citations

Abstract

Purpose: To determine the maximum tolerated dose of upper abdominal low-dose fractionated radiotherapy (<1.0 Gy per fraction) given in combination with, and as a chemopotentiator for, gemcitabine. Methods and Materials: Gemcitabine was given at 1,250 mg/m2 at 10 mg/m2/min on Days 1 and 8 of a 3-week cycle. Low-dose fractionated radiotherapy was tested at two dose levels: 60 cGy per fraction and 70 cGy per fraction. Radiotherapy was given b.i.d. on Days 1, 2, 8, and 9. Four cycles were planned. Results: Twenty-seven patients have been put on study. Ten patients have been entered in Phase I: 6 with metastatic/recurrent pancreatic carcinoma and 4 with unresectable pancreatic/small bowel carcinoma. Two of four patients at Dose Level 2 experienced dose-limiting toxicity. The overall radiographic response was 30%, and median survival was 11 months (range, 4-37 months). Conclusion: Low-dose fractionated radiotherapy to the upper abdomen is well tolerated at 60 cGy per fraction when combined with gemcitabine. Phase II evaluation is ongoing.

Original languageEnglish
Pages (from-to)172-177
Number of pages6
JournalInternational Journal of Radiation Oncology Biology Physics
Volume68
Issue number1
DOIs
StatePublished - May 1 2007

Bibliographical note

Funding Information:
Supported in part by a grant from Eli-Lilly and Company.

Keywords

  • Chemopotentiator
  • Gemcitabine
  • Pancreas
  • Radiotherapy

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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