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Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00265811
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Tracking Information
First Submitted Date  ICMJE December 14, 2005
First Posted Date  ICMJE December 15, 2005
Last Update Posted Date May 30, 2016
Study Start Date  ICMJE November 2005
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
Disease-free survival [ Time Frame: May 2012 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00265811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
  • 3-year disease-free survival [ Time Frame: May 2012 ]
  • Overall survival [ Time Frame: May 2012 ]
  • 5-year overall survival [ Time Frame: May 2012 ]
  • Treatment compliance [ Time Frame: May 2012 ]
  • Identification of prognostic factors [ Time Frame: May 2012 ]
  • Safety [ Time Frame: May 2012 ]
  • Markers predictive for relapse and/or treatment efficacy [ Time Frame: May 2012 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery
Official Title  ICMJE Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.

Detailed Description

OBJECTIVES:

Primary

  • Compare the disease-free survival rates in patients with completely resected stage III colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil with vs without cetuximab.

Secondary

  • Compare the 3-year disease-free survival rate and 5-year overall survival rate in patients treated with these regimens.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the treatment compliance of patients treated with these regimens.
  • Determine the prognostic factors and markers predictive for relapse and/or treatment efficacy in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.

OUTLINE: This is an open-label, randomized, controlled, multicenter study. Patients are stratified according to obstruction/perforation status (no obstruction and no perforation vs obstruction and/or perforation), N stage (N1 vs N2), and T stage (T1-3 vs T4). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.
  • Arm II: Patients receive chemotherapy as in arm I plus cetuximab IV over 1-2 hours on days 1 and 8.

In both arms, treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for approximately 5 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Folfox + Cetuximab
  • Drug: Folfox
Study Arms  ICMJE
  • Experimental: Folfox+Cetuximab
    FOLFOX-4 Cetuximab alone every 2 weeks
    Intervention: Drug: Folfox + Cetuximab
  • Active Comparator: Folfox
    FOLFOX-4 alone every 2 weeks
    Intervention: Drug: Folfox
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2016)
2559
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III adenocarcinoma of the colon
  • Must have undergone curative resection (R0) within the past 28-56 days

    • No radiotherapy prior to surgery
  • carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery
  • No rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery
  • No metastatic spread at baseline assessment
  • No prior or concurrent CNS disease by physical exam

PATIENT CHARACTERISTICS:

Performance status

  • WHO 0-1

Life expectancy

  • At least 5 years

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL

Hepatic

  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No coronary artery disease
  • No myocardial infarction within the past 12 months
  • No high risk of uncontrolled arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No inflammatory bowel disease
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to any of the components of the study drugs
  • No medical, geographical, sociological, psychological, or legal condition that would preclude study participation
  • No peripheral neuropathy ≥ grade 1
  • No other significant disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy

Radiotherapy

  • See Disease Characteristics
  • No prior abdominal or pelvic irradiation

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery
  • More than 28 days since prior major surgical procedure or open biopsy
  • No concurrent major surgical procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00265811
Other Study ID Numbers  ICMJE CDR0000453839
FFCD-PETACC-8 ( Other Identifier: FFCD )
EU-20547
2005-003463-23 ( EudraCT Number )
PETACC-8
MERCK-FFCD-PETACC-8
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Federation Francophone de Cancerologie Digestive
Study Sponsor  ICMJE Federation Francophone de Cancerologie Digestive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Julien Taieb, MD CHU Pitie-Salpetriere
PRS Account Federation Francophone de Cancerologie Digestive
Verification Date December 2006

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