Trial record 1 of 1 for:    CALGB-80702
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01150045
First received: June 23, 2010
Last updated: July 31, 2015
Last verified: July 2015

June 23, 2010
July 31, 2015
June 2010
December 2019   (final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01150045 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
  • Recurrence-free survival [ Designated as safety issue: No ]
  • Overall survival at 3 years [ Designated as safety issue: No ]
  • Toxicity of celecoxib [ Designated as safety issue: Yes ]
  • Cardiovascular-specific events [ Designated as safety issue: Yes ]
  • Differences in toxicity, particularly cumulative peripheral neuropathy, of 6 vs 12 courses of FOLFOX [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more information. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. The primary and secondary objectives for the research study are described below.

Primary objective:

1. To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib 400 mg daily.

Secondary objectives:

  1. To contribute to an international prospective pooled analysis that will compare disease-free survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
  2. To compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.
  3. To contribute to an international prospective pooled analysis that will compare overall survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy.
  4. To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage III colon cancer.
  5. To assess differences in cardiovascular-specific events with celecoxib versus placebo in a population of stage III colon cancer survivors.
  6. To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, for patients treated with 6 treatments of FOLFOX compared to those treated with 12 treatments of FOLFOX.

After completion of study therapy, patients are followed up every 6 months for up to 6 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: celecoxib
    Patients receive celecoxib 400 mg administered by mouth, once daily.
  • Drug: 5-fluorouracil
    Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours.
  • Other: placebo
    Patients receive placebo administered by mouth, once daily.
  • Drug: oxaliplatin
    Patients receive 85 mg/m^2 intravenous over two hours.
  • Drug: leucovorin
    Patients receive 400 mg/m^2 intravenous over two hours.
  • Active Comparator: Arm A - FOLFOX and placebo (12 treatments)
    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.
    Interventions:
    • Drug: 5-fluorouracil
    • Other: placebo
    • Drug: oxaliplatin
    • Drug: leucovorin
  • Experimental: Arm B - FOLFOX and celecoxib (12 treatments)
    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.
    Interventions:
    • Drug: celecoxib
    • Drug: 5-fluorouracil
    • Drug: oxaliplatin
    • Drug: leucovorin
  • Active Comparator: Arm C - FOLFOX and placebo (6 treatments)
    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.
    Interventions:
    • Drug: 5-fluorouracil
    • Other: placebo
    • Drug: oxaliplatin
    • Drug: leucovorin
  • Experimental: Arm D - FOLFOX and celecoxib (6 treatments)
    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.
    Interventions:
    • Drug: celecoxib
    • Drug: 5-fluorouracil
    • Drug: oxaliplatin
    • Drug: leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
Not Provided
December 2019   (final data collection date for primary outcome measure)
  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
Both
18 Years and older
No
Contact: Jeffrey A. Meyerhardt, MD, MPH 617-632-5136
United States,   Canada,   Puerto Rico
 
NCT01150045
CALGB-80702, U10CA031946, CALGB-80702, CDR0000675693
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Principal Investigator: Jeffrey A. Meyerhardt, MD, MPH Dana-Farber Cancer Institute
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP