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Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung (ERBIFORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00557102
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : December 11, 2012
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
National Cancer Institute, France

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Cancer Biological: cetuximab Biological: filgrastim Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
Study Start Date : September 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
cetuximab, FOLFIRI Biological: cetuximab
Biological: filgrastim
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium


Outcome Measures
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Primary Outcome Measures :
  1. Tumor response rate [ Time Frame: From baseline to end of treatment ]

Secondary Outcome Measures :
  1. Rate of resectability [ Time Frame: From baseline to end of treatment ]
  2. Overall and disease-free survival [ Time Frame: From baseline to end of treatment ]
  3. Tolerability [ Time Frame: From baseline to end of treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557102


Locations
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France
CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043
Sponsors and Collaborators
National Cancer Institute, France
University Hospital, Grenoble
Investigators
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Study Chair: Jean Marc Phelip, MD, PhD University Hospital, Grenoble
More Information
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Responsible Party: National Cancer Institute, France
ClinicalTrials.gov Identifier: NCT00557102    
Other Study ID Numbers: CDR0000574153
CHUG-ERBIFORT
INCA-RECF0316
EUDRACT-2007-000357-54
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012
Keywords provided by National Cancer Institute, France:
liver metastases
lung metastases
recurrent rectal cancer
stage IV rectal cancer
 adenocarcinoma of the rectum
adenocarcinoma of the colon
recurrent colon cancer
stage IV colon cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Fluorouracil
Irinotecan
Cetuximab
 Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents