Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

Summary

PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.

Timeline

Start

2010-06

Primary completion

2020-02-28

Completion

2022-08-11

Publications

• Zhang GQ, Meyerhardt JA, Shi Q, Twombly T, Pederson L, Ma C, Vayrynen JP, Zhao M, Takashima Y, Shergill A, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Tan B, O'Reilly EM, Giannakis M, Ogino S, Jurdi A, Sharma S, Aleshin A, Shields AF, Nowak JA. Predictive Role of Circulating Tumor DNA in Stage III Colon Cancer Treated With Celecoxib: A Post Hoc Analysis of the CALGB (Alliance)/SWOG 80702 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Feb 1;12(2):149-158. doi: 10.1001/jamaoncol.2025.5144.
• Nowak JA, Twombly T, Ma C, Shi Q, Haruki K, Fujiyoshi K, Vayrynen J, Zhao M, Knight J, Mane S, Shergill A, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Tan B, Philip P, O'Reilly EM, Shields AF, Ogino S, Fuchs CS, Meyerhardt JA. Improved Survival With Adjuvant Cyclooxygenase 2 Inhibition in PIK3CA-Activated Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance). J Clin Oncol. 2024 Aug 20;42(24):2853-2859. doi: 10.1200/JCO.23.01680. Epub 2024 Jun 18.
• Lee S, Ma C, Shi Q, Meyers J, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, O'Reilly EM, Shields AF, Meyerhardt JA. Sleep and cancer recurrence and survival in patients with resected Stage III colon cancer: findings from CALGB/SWOG 80702 (Alliance). Br J Cancer. 2023 Aug;129(2):283-290. doi: 10.1038/s41416-023-02290-2. Epub 2023 May 13.
• Cheng E, Shi Q, Shields AF, Nixon AB, Shergill AP, Ma C, Guthrie KA, Couture F, Kuebler P, Kumar P, Tan B, Krishnamurthi SS, Ng K, O'Reilly EM, Brown JC, Philip PA, Caan BJ, Cespedes Feliciano EM, Meyerhardt JA. Association of Inflammatory Biomarkers With Survival Among Patients With Stage III Colon Cancer. JAMA Oncol. 2023 Mar 1;9(3):404-413. doi: 10.1001/jamaoncol.2022.6911.
• Lee S, Ma C, Shi Q, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF, Meyerhardt JA. Potential Mediators of Oxaliplatin-Induced Peripheral Neuropathy From Adjuvant Therapy in Stage III Colon Cancer: Findings From CALGB (Alliance)/SWOG 80702. J Clin Oncol. 2023 Feb 10;41(5):1079-1091. doi: 10.1200/JCO.22.01637. Epub 2022 Nov 11.
• Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
• Meyerhardt JA, Shi Q, Fuchs CS, Meyer J, Niedzwiecki D, Zemla T, Kumthekar P, Guthrie KA, Couture F, Kuebler P, Bendell JC, Kumar P, Lewis D, Tan B, Bertagnolli M, Grothey A, Hochster HS, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1277-1286. doi: 10.1001/jama.2021.2454.

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