NCT01150045|CompletedPhase 3ResultsDMC

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

A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-80702U10CA031946CDR0000675693

Study Type

interventional

Target

2,527

Locations

3 countries

Sites

842

Timeline

RegisteredJun 2010

StartedJun 2010

CompletionAug 2022

Brief 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

2,527

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline

Completed

Started Jun 2010

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach

3 countries

842 active sites

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

12.2 years study duration

Study Start

First participant enrolled

June 1, 2010

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2010

Completed

9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

August 6, 2021

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed

Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

9.8 years

First QC Date

June 23, 2010

Results QC Date

May 27, 2021

Last Update Submit

April 28, 2026

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colonstage III colon cancer

Outcome Measures

Primary Outcomes (1)

Disease-free Survival
Disease-Free Survival (DFS) is defined as the time of randomization until documented progression or death from any cause. The endpoint of this trial is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive and disease free after 3 years are reported here. A log-rank test stratified with the stratification factors was used to compare disease-free survival (celecoxib vs placebo)
At 3 years of follow-up

Secondary Outcomes (1)

Overall Survival
up to 3 years from registration

Study Arms (4)

Arm A - FOLFOX and placebo (12 treatments)

ACTIVE COMPARATOR

Patients receive FOLFOX every 2 weeks plus placebo every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.

Drug: 5-fluorouracilOther: placeboDrug: oxaliplatinDrug: leucovorin

Arm B - FOLFOX and celecoxib (12 treatments)

EXPERIMENTAL

Patients receive FOLFOX every 2 weeks plus celecoxib every day for 12 treatments (24 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.

Drug: celecoxibDrug: 5-fluorouracilDrug: oxaliplatinDrug: leucovorin

Arm C - FOLFOX and placebo (6 treatments)

ACTIVE COMPARATOR

Patients receive FOLFOX every 2 weeks plus placebo every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive placebo alone every day for 3 years total.

Drug: 5-fluorouracilOther: placeboDrug: oxaliplatinDrug: leucovorin

Arm D - FOLFOX and celecoxib (6 treatments)

EXPERIMENTAL

Patients receive FOLFOX every 2 weeks plus celecoxib every day for 6 treatments (12 weeks). Each 2-week period is called a cycle. FOLFOX includes oxaliplatin, leucovorin and 5-FU.Then, patients receive celecoxib alone every day for 3 years total.

Drug: celecoxibDrug: 5-fluorouracilDrug: oxaliplatinDrug: leucovorin

Interventions

celecoxibDRUG

Patients receive celecoxib 400 mg administered by mouth, once daily.

Arm B - FOLFOX and celecoxib (12 treatments)Arm D - FOLFOX and celecoxib (6 treatments)

5-fluorouracilDRUG

Patients receive 400 mg/m\^2 intravenous bolus then 2400 mg/m\^2 continuous intravenous infusion over 46-48 hours.

Arm A - FOLFOX and placebo (12 treatments)Arm B - FOLFOX and celecoxib (12 treatments)Arm C - FOLFOX and placebo (6 treatments)Arm D - FOLFOX and celecoxib (6 treatments)

placeboOTHER

Patients receive placebo administered by mouth, once daily.

Arm A - FOLFOX and placebo (12 treatments)Arm C - FOLFOX and placebo (6 treatments)

oxaliplatinDRUG

Patients receive 85 mg/m\^2 intravenous over two hours.

Arm A - FOLFOX and placebo (12 treatments)Arm B - FOLFOX and celecoxib (12 treatments)Arm C - FOLFOX and placebo (6 treatments)Arm D - FOLFOX and celecoxib (6 treatments)

leucovorinDRUG

Patients receive 400 mg/m\^2 intravenous over two hours.

Arm A - FOLFOX and placebo (12 treatments)Arm B - FOLFOX and celecoxib (12 treatments)Arm C - FOLFOX and placebo (6 treatments)Arm D - FOLFOX and celecoxib (6 treatments)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

1. Requirements for tumor parameters 1. Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection (i.e., patients with rectal cancer are not eligible). Surgeon confirmation that the entire tumor was above the peritoneal reflection is only required in cases where it is important to establish if the tumor is a rectal or colon primary. 2. Tumors must have been completely resected. In patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon. Near or positive radial margin are not exclusions as long as en bloc resection was performed. Positive proximal margin or distal margin is an exclusion. 3. Node positive disease (N1 or N2) as designated in AJCC version 7. Either at least one pathologically confirmed positive lymph node or N1C (defined as tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases). Patients with resected stage IV disease are not eligible. 4. No evidence of residual involved lymph node disease or metastatic disease at the time of registration. 5. Patients with synchronous colon cancers are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor. However, patients with synchronous colon and rectal primary tumors are not eligible. 2. NSAID use Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average. Low-dose aspirin not exceeding 100 mg/day is permitted. Patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no was out period is required. 3. Patient history 1. No previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or any other cancer for which the patient has been disease-free for at least 5 years. 2. No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration. 3. No known allergy to platinum compounds. 4. No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs. 5. No history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Patients with ulceration, bleeding or perforation in the lower bowel are not excluded. 6. No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2. 7. No cardiac risk factors including: * Uncontrolled high blood pressure (systolic blood pressure \> 150). * Unstable angina. * History of documented myocardial infarction or cerebrovascular accident. * New York Heart Association class III or IV heart failure. 4. Pregancy/nursing status Non-pregnant and not nursing. Men and women of childbearing potential must agree to employ adequate contraception for the duration of chemotherapy and for as many as 8 weeks after the completion of chemotherapy due to the unknown teratogenic effects of FOLFOX on the developing fetus. 5. Age and performance status 1. ECOG performance status 0, 1 or 2. 2. Age at least 18 years. 6. Required initial laboratory values 1. Granulocytes ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Creatinine ≤ 1.5 times upper limit of normal (ULN) 4. Total Bilirubin ≤ 1.5 times ULN in the absence of Gilbert's disease 5. Direct bilirubin ≤ 1.5 x upper limit of normal for patients with Gilbert's syndrome

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (842)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Alaska Breast Care and Surgery LLC