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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084721 |
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving irinotecan with celecoxib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given with celecoxib in treating patients with unresectable or metastatic colorectal cancer.
Condition | Intervention | Phase |
Colorectal Cancer Diarrhea |
Drug: celecoxib Drug: irinotecan hydrochloride |
Phase I |
MedlinePlus related topics: | Cancer Colorectal Cancer Diarrhea |
ChemIDplus related topics: | Irinotecan Irinotecan hydrochloride Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Irinotecan in Combination With Fixed Dose Celecoxib in Patients With Advanced Colorectal Cancer |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of irinotecan. Patients are assigned to 1 of 2 treatment groups.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-30 patients (9 for group I, 9-21 for group II) will be accrued for this study within 1-2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent COX-2 inhibitors
United States, New York | |||||
Roswell Park Cancer Institute | |||||
Buffalo, New York, United States, 14263-0001 |
Roswell Park Cancer Institute |
National Cancer Institute (NCI) |
Principal Investigator: | Marwan Fakih, MD | Roswell Park Cancer Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000365550, RPCI-RP-0224 |
First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00084721 |
Health Authority: | United States: Federal Government |
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