NCT00003835

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,260

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

8.3 years

First QC Date

November 1, 1999

Last Update Submit

October 7, 2013

Conditions

Adenocarcinoma of the ColonStage III Colon Cancer

Outcome Measures

Primary Outcomes (2)

  • Time to recurrence

    The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.

    From time of resection until documented disease progression, assessed up to 6 years

  • Survival

    The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.

    Up to 6 years

Study Arms (2)

Arm I (leucovorin calcium and fluorouracil)

EXPERIMENTAL

Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1 hour into leucovorin calcium infusion weekly for 6 weeks. Treatment is repeated every 8 weeks for 4 courses.

Drug: leucovorin calciumDrug: fluorouracilOther: laboratory biomarker analysis

Arm II (leucovorin calcium, fluorouracil, irinotrcan)

EXPERIMENTAL

Patients receive irinotecan IV over 90 minutes, followed by leucovorin calcium IV, then followed by fluorouracil IV weekly for 4 weeks. Treatment is repeated every 6 weeks for 5 courses

Drug: leucovorin calciumDrug: fluorouracilDrug: irinotecan hydrochlorideOther: laboratory biomarker analysis

Interventions

leucovorin calciumDRUG

Given IV

Arm I (leucovorin calcium and fluorouracil)Arm II (leucovorin calcium, fluorouracil, irinotrcan)
fluorouracilDRUG

Given IV

Arm I (leucovorin calcium and fluorouracil)Arm II (leucovorin calcium, fluorouracil, irinotrcan)
irinotecan hydrochlorideDRUG

Given IV

Arm II (leucovorin calcium, fluorouracil, irinotrcan)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (leucovorin calcium and fluorouracil)Arm II (leucovorin calcium, fluorouracil, irinotrcan)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

Related Publications (11)

  • Lee 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: 35641198DERIVED

  • Symonds 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: 35412430DERIVED

  • Kosumi 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: 30826660DERIVED

  • Van 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: 30038051DERIVED

  • Van 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.

    PMID: 29710284DERIVED

  • Fadelu T, Zhang S, Niedzwiecki D, Ye X, Saltz LB, Mayer RJ, Mowat RB, Whittom R, Hantel A, Benson AB, Atienza DM, Messino M, Kindler HL, Venook A, Ogino S, Ng K, Wu K, Willett W, Giovannucci E, Meyerhardt J, Bao Y, Fuchs CS. Nut Consumption and Survival in Patients With Stage III Colon Cancer: Results From CALGB 89803 (Alliance). J Clin Oncol. 2018 Apr 10;36(11):1112-1120. doi: 10.1200/JCO.2017.75.5413. Epub 2018 Feb 28.

    PMID: 29489429DERIVED

  • Fuchs MA, Yuan C, Sato K, Niedzwiecki D, Ye X, Saltz LB, Mayer RJ, Mowat RB, Whittom R, Hantel A, Benson A, Atienza D, Messino M, Kindler H, Venook A, Innocenti F, Warren RS, Bertagnolli MM, Ogino S, Giovannucci EL, Horvath E, Meyerhardt JA, Ng K. Predicted vitamin D status and colon cancer recurrence and mortality in CALGB 89803 (Alliance). Ann Oncol. 2017 Jun 1;28(6):1359-1367. doi: 10.1093/annonc/mdx109.

    PMID: 28327908DERIVED

  • Pavelitz T, Renfro L, Foster NR, Caracol A, Welsch P, Lao VV, Grady WB, Niedzwiecki D, Saltz LB, Bertagnolli MM, Goldberg RM, Rabinovitch PS, Emond M, Monnat RJ Jr, Maizels N. MRE11-deficiency associated with improved long-term disease free survival and overall survival in a subset of stage III colon cancer patients in randomized CALGB 89803 trial. PLoS One. 2014 Oct 13;9(10):e108483. doi: 10.1371/journal.pone.0108483. eCollection 2014.

    PMID: 25310185DERIVED

  • Ogino S, Liao X, Imamura Y, Yamauchi M, McCleary NJ, Ng K, Niedzwiecki D, Saltz LB, Mayer RJ, Whittom R, Hantel A, Benson AB 3rd, Mowat RB, Spiegelman D, Goldberg RM, Bertagnolli MM, Meyerhardt JA, Fuchs CS; Alliance for Clinical Trials in Oncology. Predictive and prognostic analysis of PIK3CA mutation in stage III colon cancer intergroup trial. J Natl Cancer Inst. 2013 Dec 4;105(23):1789-98. doi: 10.1093/jnci/djt298. Epub 2013 Nov 14.

    PMID: 24231454DERIVED

  • Yothers G, Sargent DJ, Wolmark N, Goldberg RM, O'Connell MJ, Benedetti JK, Saltz LB, Dignam JJ, Blackstock AW; ACCENT Collaborative Group. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19;103(20):1498-506. doi: 10.1093/jnci/djr310. Epub 2011 Oct 12.

    PMID: 21997132DERIVED

  • McCleary NJ, Niedzwiecki D, Hollis D, Saltz LB, Schaefer P, Whittom R, Hantel A, Benson A, Goldberg R, Meyerhardt JA. Impact of smoking on patients with stage III colon cancer: results from Cancer and Leukemia Group B 89803. Cancer. 2010 Feb 15;116(4):957-66. doi: 10.1002/cncr.24866.

    PMID: 20052723DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

LeucovorinFluorouracilIrinotecan

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingCamptothecinAlkaloids

Study Officials

  • Leonard Saltz

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 27, 2004

Study Start

May 1, 1999

Primary Completion

August 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)