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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
National Cancer Institute, France
ClinicalTrials.gov Identifier:
NCT00557102
First received: November 9, 2007
Last updated: December 10, 2012
Last verified: December 2012

November 9, 2007
December 10, 2012
September 2007
December 2010   (final data collection date for primary outcome measure)
Tumor response rate [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
Tumor response rate
Complete list of historical versions of study NCT00557102 on ClinicalTrials.gov Archive Site
  • Rate of resectability [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
  • Overall and disease-free survival [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: Yes ]
  • Rate of resectability
  • Overall and disease-free survival
  • Tolerability
Not Provided
Not Provided
 
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Metastatic Cancer
  • Biological: cetuximab
  • Biological: filgrastim
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
cetuximab, FOLFIRI
Interventions:
  • Biological: cetuximab
  • Biological: filgrastim
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00557102
CDR0000574153, CHUG-ERBIFORT, INCA-RECF0316, EUDRACT-2007-000357-54
Not Provided
National Cancer Institute, France
National Cancer Institute, France
University Hospital, Grenoble
Study Chair: Jean Marc Phelip, MD, PhD University Hospital, Grenoble
National Cancer Institute, France
December 2012

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