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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00265811
First received: December 14, 2005
Last updated: April 2, 2012
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Biological: cetuximab
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab

Resource links provided by NLM:


Further study details as provided by Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3-year disease-free survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • 5-year overall survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Treatment compliance [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Identification of prognostic factors [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: May 2012 ] [ Designated as safety issue: Yes ]
  • Markers predictive for relapse and/or treatment efficacy [ Time Frame: May 2012 ] [ Designated as safety issue: No ]

Enrollment: 2564
Study Start Date: November 2005
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265811

Locations
France
Hopital Duffaut
Avignon, France, 84902
CHU de Caen
Caen, France, 14033
Hopital Robert Boulin
Libourne, France, 33500
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Tenon
Paris, France, 75970
Hopital Bichat - Claude Bernard
Paris, France, 75018
Centre Hospitalier Yves Le Foll
Saint Brieuc Cedex 1, France, BP 2367
Nouvelle Clinique Generale
Valence, France, 26000
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Julien Taieb, MD CHU Pitie-Salpetriere
  More Information

Additional Information:
Publications:
Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00265811     History of Changes
Other Study ID Numbers: CDR0000453839, FFCD-PETACC-8, EU-20547, EUDRACT-2005-003463-23, PETACC-8, MERCK-FFCD-PETACC-8
Study First Received: December 14, 2005
Last Updated: April 2, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: The Danish National Committee on Biomedical Research Ethics
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
United Kingdom: National Institute for Health Research

Keywords provided by Federation Francophone de Cancerologie Digestive:
stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on October 19, 2014