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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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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 |
---|---|---|
Cancer-Related Problem/Condition Colorectal Cancer |
Drug: celecoxib Drug: irinotecan hydrochloride |
Phase I |
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 |
Principal Investigator: | Marwan Fakih, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000365550, RPCI-RP-0224 |
Study First Received: | June 10, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00084721 |
Health Authority: | United States: Federal Government |
diarrhea recurrent colon cancer stage IV colon cancer recurrent rectal cancer |
stage IV rectal cancer stage III colon cancer stage III rectal cancer |
Celecoxib Diarrhea Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Intestinal Diseases Rectal Diseases |
Camptothecin Recurrence Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |