A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer
PRIMARY OBJECTIVES:
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.
Interventional
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
7 days
Yes
David Ryan
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-02357
NCT00006094
July 2000
Name | Location |
---|---|
Cancer and Leukemia Group B | Chicago, Illinois 60606 |