Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 to 74 Other, Pharmaceutical / Industry FFCD-PETACC-8 EU-20547, EUDRACT-2005-003463-23, PETACC-8, MERCK-FFCD-PETACC-8, NCT00265811

Objectives

Primary

1. 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

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

Entry 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

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

Patient Characteristics:

Performance status

• WHO 0-1

Life expectancy

• At least 5 years

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Disease-free survival

3-year disease-free survival
Overall survival
5-year overall survival
Treatment compliance
Identification of prognostic factors
Safety
Markers predictive for relapse and/or treatment efficacy

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.

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 8 (2): 183-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Federation Francophone de Cancerologie Digestive

Julien Taieb, MD, Protocol chair		Ph: 33-1-4216-1023

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

Registry Information
Official Title		Adjuvant Treatment of Fully Resected Stage III Colon Cancer with FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab
Trial Start Date		2005-11-01
Trial Completion Date		2014-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00265811
Date Submitted to PDQ		2005-09-14
Information Last Verified		2006-12-03