A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer
- Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when
given in combination with continuous-infusion fluorouracil and radiotherapy in patients
with primary cancer of the thoracic esophagus or gastroesophageal junction.
- Determine the pharmacokinetics of this regimen in this patient population.
- Assess somatic p53 mutations in cancer of the esophagus and determine their relation to
therapeutic response induced by this regimen.
- Assess, in a preliminary manner, the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil.
Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV
continuously on days 8-42. Patients also undergo radiotherapy once daily, 5 days a week, for
6 weeks beginning on day 8.
Patients without evidence of distant disease or unresectable local regional invasion undergo
esophageal resection between days 63-70 (within 3-4 weeks after completion of
chemoradiotherapy). Patients then receive oxaliplatin as above on days 105, 119, and 133 and
fluorouracil as above on days 105-147.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within
approximately 3 years.
Primary Purpose: Treatment
Lawrence P. Leichman, MD
Albany Medical College
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|