- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003544
Irinotecan in Treating Patients With Metastatic Colorectal Cancer
A Phase II Trial of Preoperative Irinotecan (CPT-11) in Patients With High-Risk Resectable Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with metastatic colorectal cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Evaluate the clinical usefulness of preoperative irinotecan in patients with high risk, technically resectable metastatic colorectal cancer that is refractory to fluorouracil. II. Evaluate prospectively the relationship between expression of selected molecular determinants of response and clinical responsiveness to irinotecan in these patients. III. Determine the effect of treatment with irinotecan on the expression of putative response determinants in these patients.
OUTLINE: This is an open label study. Patients receive irinotecan IV over 90 minutes weekly for 4 consecutive weeks. Course repeats every 6 weeks. After 2 courses, CT scan is obtained and patients showing evidence of disease that is still amenable to surgical resection undergo surgery. Approximately 4-8 weeks after surgical resection, patients receive 3 additional courses of irinotecan in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for years 3 and 4.
PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed technically resectable metastatic colorectal cancer that is high risk for relapse Must meet one of the following criteria: Metastatic colorectal cancer confined to liver plus portal lymph nodes Recurrent metastatic colorectal cancer confined to liver after first hepatic resection Metastatic colorectal cancer confined to lung plus liver Metastatic colorectal cancer confined to liver with MSKCC risk factor score greater than 4 Metastatic colorectal cancer confined to lung, with either greater than 1 nodule and/or less than 3 years disease free survival Metastatic colorectal cancer confined to ovary Metastatic colorectal cancer confined to a single intraabdominal lymph node Must have failed fluorouracil-based chemotherapy for metastatic disease, received fluorouracil-based chemotherapy in adjuvant setting, have tumor with measured thymidylate synthase level greater than 4.0, or have lung metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No myocardial infarction in the last 6 months Other: No other prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No active or uncontrolled infection No psychiatric or other disorders No other concurrent disease that would preclude entry into this study Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior irinotecan or other camptothecins Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 98-057
- CDR0000066598 (Registry Identifier: PDQ (Physician Data Query))
- NCI-G98-1476
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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