Combination Chemotherapy in Treating Patients With Stage III Colon Cancer

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Patients must have histologically documented adenocarcinoma of the colon; the gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection; tumor must have been completely resected, including negative radial resecting margins
* There must be no history of distant metastatic disease at the time of registration
* Pathological evaluation must show Modified Astler-Coller stage C (TxN1-2M0) disease
* No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years
* Zubrod performance status of 0-2
* Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
* Granulocytes \>= 1,500/ul
* Platelet count \>= 100,000/ul
* Creatinine =\< 1.5 x upper limits of normal
* Bilirubin =\< upper limit of normal

• DERIVEDLee S, Ma C, Zhang S, Ou FS, Bainter TM, Niedzwiecki D, Saltz LB, Mayer RJ, Whittom R, Hantel A, Benson A, Atienza D, Kindler H, Gross CP, Irwin ML, Meyerhardt JA, Fuchs CS. Marital Status, Living Arrangement, and Cancer Recurrence and Survival in Patients with Stage III Colon Cancer: Findings from CALGB 89803 (Alliance). Oncologist. 2022 Jun 8;27(6):e494-e505. doi: 10.1093/oncolo/oyab070. PMID 35641198
• DERIVEDSymonds L, Yu M, Zhang Y, Ou FS, Zemla TJ, Carter K, Bertagnolli M, Innocenti F, Bosch LJ, Meijer GA, Carvalho B, Grady WM, Cohen SA. Evaluation of methylated DCR1 as a biomarker for response to adjuvant irinotecan-based therapy in stage III colon cancer: cancer and leukaemia Group B 89803 (Alliance). Epigenetics. 2022 Dec;17(12):1715-1725. doi: 10.1080/15592294.2022.2058225. Epub 2022 Apr 12. PMID 35412430
• DERIVEDKosumi K, Hamada T, Zhang S, Liu L, da Silva A, Koh H, Twombly TS, Mima K, Morikawa T, Song M, Nowak JA, Nishihara R, Saltz LB, Niedzwiecki D, Ou FS, Zemla T, Mayer RJ, Baba H, Ng K, Giannakis M, Zhang X, Wu K, Giovannucci EL, Chan AT, Fuchs CS, Meyerhardt JA, Ogino S. Prognostic association of PTGS2 (COX-2) over-expression according to BRAF mutation status in colorectal cancer: Results from two prospective cohorts and CALGB 89803 (Alliance) trial. Eur J Cancer. 2019 Apr;111:82-93. doi: 10.1016/j.ejca.2019.01.022. Epub 2019 Mar 1. PMID 30826660
• DERIVEDVan Blarigan EL, Ou FS, Niedzwiecki D, Zhang S, Fuchs CS, Saltz L, Mayer RJ, Venook A, Ogino S, Song M, Benson A, Hantel A, Atkins JN, Giovannucci EL, Meyerhardt JA. Dietary Fat Intake after Colon Cancer Diagnosis in Relation to Cancer Recurrence and Survival: CALGB 89803 (Alliance). Cancer Epidemiol Biomarkers Prev. 2018 Oct;27(10):1227-1230. doi: 10.1158/1055-9965.EPI-18-0487. Epub 2018 Jul 23. PMID 30038051
• DERIVEDVan Blarigan EL, Fuchs CS, Niedzwiecki D, Zhang S, Saltz LB, Mayer RJ, Mowat RB, Whittom R, Hantel A, Benson A, Atienza D, Messino M, Kindler H, Venook A, Ogino S, Giovannucci EL, Ng K, Meyerhardt JA. Association of Survival With Adherence to the American Cancer Society Nutrition and Physical Activity Guidelines for Cancer Survivors After Colon Cancer Diagnosis: The CALGB 89803/Alliance Trial. JAMA Oncol. 2018 Jun 1;4(6):783-790. doi: 10.1001/jamaoncol.2018.0126.