- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557102
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung (ERBIFORT)
Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
RATIONALE: 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. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the tumor response rate in patients with colorectal cancer and hepatic and/or pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.
Secondary
- Determine the rate of resectability in patients treated with this regimen.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes on days 1 and 8. Patients also receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2. Patients with 7/6 or 7/7 genotypes also receive filgrastim (G-CSF) as primary prophylaxis (patients with 6/6 genotypes receive G-CSF as secondary prophylaxis). Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after the completion of cetuximab and FOLFIRI chemotherapy, patients with responding disease undergo surgical resection of visceral metastases.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Grenoble, France, 38043
- CHU de Grenoble - Hôpital Michallon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
Must have synchronous or metasynchronous unresectable hepatic metastases
- Less than 8 hepatic metastases
- Less than 6 segments of liver involvement with metastases
- No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases
- Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible
- At least 1 measurable metastasis by CT scan or MRI
- No brain metastases, bone metastases, or carcinomatous meningitis
- No celiac lymph node involvement or peritoneal cancer
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 3 months
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- PT rate > 70%
- Bilirubin < 30 μmol/L
- Creatinine < 130 μmol/L
- Creatinine clearance > 60 mL/min
- Not pregnant or nursing
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No severe unstable angina
- No symptomatic heart failure
- No other concurrent illness
PRIOR CONCURRENT THERAPY:
- At least 3 months since prior adjuvant anticancer chemotherapy
- No concurrent participation in another clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: cetuximab, FOLFIRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor response rate
Time Frame: From baseline to end of treatment
|
From baseline to end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of resectability
Time Frame: From baseline to end of treatment
|
From baseline to end of treatment
|
Overall and disease-free survival
Time Frame: From baseline to end of treatment
|
From baseline to end of treatment
|
Tolerability
Time Frame: From baseline to end of treatment
|
From baseline to end of treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jean Marc Phelip, MD, PhD, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Leucovorin
- Irinotecan
- Calcium
- Levoleucovorin
- Cetuximab
Other Study ID Numbers
- CDR0000574153
- CHUG-ERBIFORT
- INCA-RECF0316
- EUDRACT-2007-000357-54
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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