A Phase II Study of Celecoxib With Irinotecan, 5-Fluorouracil, and Leucovorin in Patients With Previously Untreated Advanced or Metastatic Colorectal Cancer

American Journal of Clinical Oncology
Emerson Y ChenCharles D Lopez

Abstract

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. Cyclooxygenase-2 (COX-2) overexpression is associated with increased tumor invasiveness and proliferation in CRC, and COX-2 inhibition has demonstrated chemopreventive activity. This study investigated the addition of celecoxib, a selective COX-2 inhibitor, to the irinotecan, 5-fluorouracil, and leucovorin (IFL) regimen for patients with previously untreated metastatic CRC. Forty-seven patients enrolled in this single-arm phase II study received celecoxib at 400 mg orally twice daily in combination with weekly irinotecan (125 mg/m(2)), 5-fluorouracil (500 mg/m(2)), and leucovorin (20 mg/m(2)) for 4 weeks every 6 weeks. The primary endpoint was response rate (RR) as measured by Response Evaluation Criteria in Solid Tumors. The protocol was amended midway to additionally exclude patients with Eastern Cooperative Oncology Group performance status 2 and require all patients with specific cardiovascular risk factors to take daily aspirin (81 mg). The objective RR was 31.9% (95% confidence interval [CI], 19%-47%). Median progression-free survival was 8.7 months (95% CI, 5.8-10.6), and the median overall survival was 19.7 months (95% CI, 15.4-22....Continue Reading

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Citations

Apr 18, 2020·Experimental & Molecular Medicine·So-Yeon Park, Jeong-Seok Nam
May 16, 2019·Cellular and Molecular Life Sciences : CMLS·Winnie Fong, Kenneth K W To
Jan 5, 2021·Medical Oncology·Jamal Majidpoor, Keywan Mortezaee
Jun 25, 2020·European Journal of Surgical Oncology : the Journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology·Tao HouYao Liang
Jun 17, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Shuangshuang LiShuwen Yu

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Methods Mentioned

BETA
biopsy

Clinical Trials Mentioned

NCT01150045

Software Mentioned

SAS

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