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Phase III Randomized Study of Adjuvant Combination Chemotherapy Comprising Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Cetuximab in Patients With Completely Resected Stage III Colon Cancer
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
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Protocol IDs
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Phase III
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Treatment
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Active
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18 to 74
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Other, Pharmaceutical / Industry
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FFCD-PETACC-8 EU-20547, EUDRACT-2005-003463-23, PETACC-8, MERCK-FFCD-PETACC-8, NCT00265811
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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.
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 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 Life expectancy 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 2000A total of 2,000 patients will be accrued for this study. Outcomes Primary Outcome(s)Disease-free survival
Secondary Outcome(s)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. Published ResultsTaieb 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 | | | | Trial Sites
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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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