Phase I-II Study of Weekly CPT-11 and Radiation Therapy for Unresectable or Locally Recurrent Large Bowel Cancer
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of weekly irinotecan that will
result in an acceptable level of toxicity when given in combination with concurrent external
beam radiation therapy. II. Determine the objective response rate of these patients at the
dose level below the MTD.
OUTLINE: Patients receive irinotecan IV over 90 minutes beginning within 24 hours of
radiotherapy on days 1, 8, 15, and 22. External beam radiotherapy is administered 5 days per
week for 5.5-6 weeks starting on day 1 concurrent with chemotherapy. Cohorts of 3-6 patients
are treated until the maximum tolerated dose (MTD) has been determined. The MTD is defined
as the dose level at which the incidence of dose limiting toxicity is no greater than
one-third of the patients treated at that dose level. Once the MTD has been determined,
additional patients receive irinotecan at the dose level below the MTD with external beam
radiation therapy on the same treatment schedule as above. Patients are followed at 4 weeks
after treatment, then every 3 months for 2 years, and then every 6 months for 3 additional
years.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into the Phase I portion of
this study. Approximately 15-25 patients will be accrued into the Phase II portion of this
study.
Interventional
Primary Purpose: Treatment
Charles R. Thomas, MD
Study Chair
University of Texas Health Science Center at San Antonio
United States: Federal Government
CDR0000066321
NCT00003344
August 1998
January 2000
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |