MedPath

Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
Metastatic Cancer
Interventions
Registration Number
NCT00056030
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer.

Detailed Description

OBJECTIVES:

* Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin, fluorouracil, leucovorin calcium, and cetuximab.

* Determine the response rate and overall survival of patients treated with this regimen.

* Determine the quality of life of patients treated with this regimen.

* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease.

Quality of life is assessed at baseline and prior to each treatment course.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 67-73 patients will be accrued for this study within 4 years.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
73
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
cetuximab + oxaliplatin + leucovorin + fluorouracilleucovorin calciumPatients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
cetuximab + oxaliplatin + leucovorin + fluorouracilcetuximabPatients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
cetuximab + oxaliplatin + leucovorin + fluorouracilfluorouracilPatients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
cetuximab + oxaliplatin + leucovorin + fluorouraciloxaliplatinPatients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1 and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses or until deemed to have resectable disease. Quality of life is assessed at baseline and prior to each treatment course. Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
Primary Outcome Measures
NameTimeMethod
Surgical resectability rate as assessed by surgical resection of liver metastasesUp to 4 years
Secondary Outcome Measures
NameTimeMethod
Overall survivalUp to 4 years
Quality of life as assessed by UNISCALE and Symptom Distress Scale every 6 weeksUp to 4 years
Response rate as measured by RECIST criteria every 6 weeksUp to 4 years

Trial Locations

Locations (158)

Mobile Infirmary Medical Center

🇺🇸

Mobile, Alabama, United States

Mayo Clinic Scottsdale

🇺🇸

Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville

🇺🇸

Jacksonville, Florida, United States

Rush-Copley Cancer Care Center

🇺🇸

Aurora, Illinois, United States

St. Joseph Medical Center

🇺🇸

Bloomington, Illinois, United States

Graham Hospital

🇺🇸

Canton, Illinois, United States

Memorial Hospital

🇺🇸

Carthage, Illinois, United States

Eureka Community Hospital

🇺🇸

Eureka, Illinois, United States

Galesburg Clinic, PC

🇺🇸

Galesburg, Illinois, United States

Galesburg Cottage Hospital

🇺🇸

Galesburg, Illinois, United States

Scroll for more (148 remaining)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.