Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery
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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 |
- Disease-free survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
- 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) |
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 |
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| 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 | |
| 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:
|
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 May 23, 2013