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

Sponsor:	Federation Francophone de Cancerologie Digestive
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00265811

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Oxaliplatin Cetuximab Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	2000
Study Start Date:	November 2005
Estimated Primary Completion Date:	December 2014 (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
Carcinoembryogenic 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

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

Locations

France
Hopital Duffaut	Recruiting
Avignon, France, 84902
Contact: Ahmed Azzedine 33-4-3275-3121
CHU de Caen	Recruiting
Caen, France, 14033
Contact: Dominique Arsene 33-2-3106-4514
Hopital Robert Boulin	Recruiting
Libourne, France, 33500
Contact: Dominique Auby 33-5-5755-3552 dominique.auby@cheibourne.aquisante.fr
CHU Pitie-Salpetriere	Recruiting
Paris, France, 75651
Contact: Julien Taieb, MD 33-1-4216-1023
Hopital Tenon	Recruiting
Paris, France, 75970
Contact: Xavier Amiot 33-1-4030-7000
Hopital Bichat - Claude Bernard	Recruiting
Paris, France, 75018
Contact: Thomas Aparicio 33-1-4025-7200 thomas.aparicio@bch.ap-hop-paris.fr
Centre Hospitalier Yves Le Foll	Recruiting
Saint Brieuc Cedex 1, France, BP 2367
Contact: Corinne Alleaume 33-2-9601-7123
Nouvelle Clinique Generale	Recruiting
Valence, France, 26000
Contact: Philippe Amoyal, MD 33-4-7578-2466 philippe.amoyal@wanadoo.fr

Sponsors and Collaborators

Federation Francophone de Cancerologie Digestive

Investigators

Study Chair:

Julien Taieb, MD

CHU Pitie-Salpetriere

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Taieb J, Puig PL, Bedenne L. Cetuximab plus FOLFOX-4 for fully resected stage III colon carcinoma: scientific background and the ongoing PETACC-8 trial. Expert Rev Anticancer Ther. 2008 Feb;8(2):183-9.

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:	February 6, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:

Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adjuvants, Immunologic
Fluorouracil
Oxaliplatin

Cetuximab
Leucovorin
Levoleucovorin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Vitamin B Complex
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on February 09, 2012