Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus irinotecan in treating patients with colon cancer that is recurrent or that cannot be removed surgically.
|Colorectal Cancer||Drug: irinotecan hydrochloride Radiation: radiation therapy||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I-II Study of Weekly CPT-11 and Radiation Therapy for Unresectable or Locally Recurrent Large Bowel Cancer|
|Study Start Date:||August 1998|
|Study Completion Date:||January 2000|
|Primary Completion Date:||January 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003344
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425-0721|
|Study Chair:||Charles R. Thomas, MD||The University of Texas Health Science Center at San Antonio|