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Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: April 6, 2009   History of Changes
Sponsored by: Medical University of South Carolina
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003344
  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.


Condition Intervention Phase
Colorectal Cancer
Drug: irinotecan hydrochloride
Radiation: radiation therapy
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I-II Study of Weekly CPT-11 and Radiation Therapy for Unresectable or Locally Recurrent Large Bowel Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 49
Study Start Date: August 1998
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003344

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Study Chair: Charles R. Thomas, MD University of Texas
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066321, MUSC-7532, HCC/MUSC-GI-01, NCI-V98-1420
Study First Received: November 1, 1999
Last Updated: April 6, 2009
ClinicalTrials.gov Identifier: NCT00003344     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II colon cancer
stage III colon cancer
stage II rectal cancer
stage III rectal cancer
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Camptothecin
Recurrence
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Camptothecin
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009