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Clinical Study

A Phase II Trial of Irinotecan, 5-Fluorouracil and Leucovorin Combined with Celecoxib and Glutamine as First-Line Therapy for Advanced Colorectal Cancer

Pan C.-X.a · Loehrer P.a · Seitz D.a · Helft P.a · Juliar B.b · Ansari R.c · Pletcher W.d · Vinson J.e · Cheng L.f · Sweeney C.a

Author affiliations

aDepartment of Medicine, Division of Hematology/Oncology, bDivision of Biostatistics, Indiana University School of Medicine, Indianapolis, Ind., cNorthern Indiana Cancer Research Consortium, South Bend, Ind., dElkhart Clinic, Elkhart, Ind., eHoosier Oncology Group, fDepartment of Pathology, Indiana University School of Medicine, Indianapolis, Ind., USA

Related Articles for ""

Oncology 2005;69:63–70

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Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: July 21, 2004
Accepted: January 29, 2005
Published online: September 01, 2005
Issue release date: August 2005

Number of Print Pages: 8
Number of Figures: 2
Number of Tables: 2

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL

Abstract

Objectives: Preclinical and clinical data indicate that cyclooxygenase-2 (COX-2) is a bona fide molecular target for colorectal cancer (CRC). Glutamine may decrease chemotherapy-associated diarrhea. This study was designed to address whether the addition of celecoxib, a COX-2 inhibitor, and glutamine would improve the efficacy and decrease the toxicities of the irinotecan, fluorouracil and leucovorin (IFL) regimen. Methods: All patients received the original IFL regimen plus celecoxib (400 mg, po, every 12 h continuously while on trial) and glutamine (10 g, po, every 8 h continuously while on chemotherapy). Results: Of the 41 patients enrolled, 40 patients received between 1 and 6 cycles of treatment. This regimen was associated with significant toxicities: 45.0% had grade 3 diarrhea, 35.0% grade 3/4 neutropenia, 22.5% hospitalization, 10.0% deep vein thrombosis and 2 treatment-related deaths. The overall response rate was 47.2%. The median progression-free survival was 6.7 months. The median overall survival was 16.3 months. The 12-month overall survival rate was 54.8%. COX-2 expression was present in 63.2% of the specimens evaluated. There was no significant correlation between COX-2 expression and response to chemotherapy (p = 0.739). Conclusion: The addition of celecoxib and glutamine appears not to improve the efficacy or decrease the toxicities of IFL for the treatment of metastatic CRC.

© 2005 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: July 21, 2004
Accepted: January 29, 2005
Published online: September 01, 2005
Issue release date: August 2005

Number of Print Pages: 8
Number of Figures: 2
Number of Tables: 2

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL


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