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

Colorectal Cancer Clinical Trial

— ERBIFORT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557102
• Other study ID #: CDR0000574153
• Secondary ID: CHUG-ERBIFORTINC
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2007
• Last updated: December 10, 2012
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2012
• Source: National Cancer Institute, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Biological:
• cetuximab

• filgrastim

Drug:
• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

Locations

Country	Name	City	State
France	CHU de Grenoble - Hopital Michallon	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute, France	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response rate		From baseline to end of treatment	No
Secondary	Rate of resectability		From baseline to end of treatment	No
Secondary	Overall and disease-free survival		From baseline to end of treatment	No
Secondary	Tolerability		From baseline to end of treatment	Yes