Overview

Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer

Status:
Completed

Trial end date:
2000-01-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Medical University of South Carolina

Treatments:

Irinotecan

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed unresectable, incompletely resected with
gross residual disease, or locally recurrent large bowel carcinoma confined to a site
within the abdomen or pelvis All disease must be encompassable within a single radiotherapy
port No evidence of uncontrolled metastatic disease outside of the planned radiotherapy
port

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Not specified
Cardiovascular: No history of significant myocardial disease No New York Heart Association
class III or IV disease No unstable angina No myocardial infarction in the past 4 months
Other: No significant infection or other coexistent medical condition that would preclude
protocol therapy Maintain an adequate oral nutrition intake (at least 1,200 calories
estimated per day) No greater than 6 bowel movements per day prior to treatment No
significant nausea or emesis on optimal antiemetic therapy Not pregnant or nursing
Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior irinotecan
Endocrine therapy: Not specified Radiotherapy: No prior abdominal or pelvic radiotherapy
Surgery: At least 3 weeks since laparotomy or laparoscopic procedure with or without
resection