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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

Tracking Information
First Submitted Date  ICMJE November 9, 2007
First Posted Date  ICMJE November 12, 2007
Last Update Posted Date December 11, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)		 Tumor response rate [ Time Frame: From baseline to end of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2007)		 Tumor response rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • Rate of resectability [ Time Frame: From baseline to end of treatment ]
  • Overall and disease-free survival [ Time Frame: From baseline to end of treatment ]
  • Tolerability [ Time Frame: From baseline to end of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2007)
  • Rate of resectability
  • Overall and disease-free survival
  • Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung
Official Title  ICMJE Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Metastatic Cancer
Intervention  ICMJE
  • Biological: cetuximab
  • Biological: filgrastim
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Study Arms  ICMJE cetuximab, FOLFIRI
Interventions:
  • Biological: cetuximab
  • Biological: filgrastim
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012)		 24
Original Enrollment  ICMJE
 (submitted: November 9, 2007)		 36
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00557102
Other Study ID Numbers  ICMJE CDR0000574153
CHUG-ERBIFORT
INCA-RECF0316
EUDRACT-2007-000357-54
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Cancer Institute, France
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE National Cancer Institute, France
Original Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE University Hospital, Grenoble
Investigators  ICMJE
Study Chair: Jean Marc Phelip, MD, PhD University Hospital, Grenoble
PRS Account National Cancer Institute, France
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP