Charleston, South Carolina 29425

  • Colorectal Cancer

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000066321


NCT ID:

NCT00003344


Secondary ID:

MUSC-7532


Study Acronym:


Brief Title:

Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer


Official Title:

Phase I-II Study of Weekly CPT-11 and Radiation Therapy for Unresectable or Locally Recurrent Large Bowel Cancer


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

49


Enrollment Type:


Overall Contact Information

Official Name:Charles R. Thomas, MD
Study Chair
The University of Texas Health Science Center at San Antonio

Study Dates

Start Date:August 1998
Completion Date:January 2000
Completion Type:Actual
Primary Completion Date:January 2000
Primary Completion Type:Actual
Verification Date:May 2018
Last Changed Date:May 11, 2018
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Radiation
Name:radiation therapy
Intervention Type:Drug
Name:irinotecan hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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