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

Phase 2

Completed

• Conditions: Colorectal Cancer; Metastatic Cancer
• Interventions: Biological: cetuximab; Biological: filgrastim; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

• Registration Number: NCT00557102
• Lead Sponsor: National Cancer Institute, France

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cetuximab, FOLFIRI	leucovorin calcium	-
cetuximab, FOLFIRI	cetuximab	-
cetuximab, FOLFIRI	filgrastim	-
cetuximab, FOLFIRI	fluorouracil	-
cetuximab, FOLFIRI	irinotecan hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Tumor response rate	From baseline to end of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Grenoble - Hopital Michallon; 🇫🇷 Grenoble, France