A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer
I. Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and
external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum.
(Phase I closed to accrual effective 03/27/2003). II. Determine the pathological response
rate in patients treated with this preoperative regimen and surgical resection.
III.Determine the late toxicity of this preoperative regimen in these patients. IV.
Determine, in a preliminary manner, the progression-free survival, local control, and
overall survival in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study of oxaliplatin.
Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days
1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in
the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at that dose level in the phase II portion of the study. (Phase I closed to
accrual effective 03/27/2003). Patients may undergo radical resection of rectal tumor within
4-6 weeks after completion of chemoradiotherapy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for phase I of the study (phase
I closed to accrual effective 03/27/2003) and a total of 19 patients will be accrued for
phase II of the study within 12-18 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas
Cancer and Leukemia Group B
United States: Food and Drug Administration
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