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
  Purpose

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 Intervention Phase
Colorectal Cancer
Metastatic Cancer
Biological: cetuximab
Biological: filgrastim
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, France:

Primary Outcome Measures:
  • Tumor response rate [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
cetuximab, FOLFIRI Biological: cetuximab Biological: filgrastim Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557102

Locations
France
CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043
Sponsors and Collaborators
National Cancer Institute, France
University Hospital, Grenoble
Investigators
Study Chair: Jean Marc Phelip, MD, PhD University Hospital, Grenoble
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute, France
ClinicalTrials.gov Identifier: NCT00557102     History of Changes
Other Study ID Numbers: CDR0000574153, CHUG-ERBIFORT, INCA-RECF0316, EUDRACT-2007-000357-54
Study First Received: November 9, 2007
Last Updated: December 10, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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:
Colonic Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Fluorouracil
Irinotecan
Cetuximab
Camptothecin
Lenograstim
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 20, 2014