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

Sponsor

National Cancer Institute, France (Other)

Overall Status

Completed

CT.gov ID

NCT00557102

Collaborator

University Hospital, Grenoble (Other)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Sep 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: cetuximab, FOLFIRI	Biological: cetuximab Biological: filgrastim Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium

Arm

Intervention/Treatment

Other: cetuximab, FOLFIRI

Biological: cetuximab

Biological: filgrastim

Drug: fluorouracil

Drug: irinotecan hydrochloride

Drug: leucovorin calcium

Outcome Measures

Primary Outcome Measures

Tumor response rate [From baseline to end of treatment]

Secondary Outcome Measures

Rate of resectability [From baseline to end of treatment]
Overall and disease-free survival [From baseline to end of treatment]
Tolerability [From baseline to end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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