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

Last Updated: 2017-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Metastatic Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cetuximab + oxaliplatin + leucovorin + fluorouracil

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.

Group Type EXPERIMENTAL

cetuximab

Intervention Type BIOLOGICAL

fluorouracil

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Interventions

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cetuximab

Intervention Type BIOLOGICAL

fluorouracil

Intervention Type DRUG

leucovorin calcium

Intervention Type DRUG

oxaliplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* History of completely resected primary adenocarcinoma of the colon or rectum

* No gross or microscopic evidence of residual disease
* Liver metastases, meeting 1 of the following criteria:

* Not optimally resectable
* Requires resection of all 3 major hepatic veins, the portal vein bifurcation, or the retrohepatic vena cava
* Includes the main right or main left portal vein and the main hepatic vein of the opposite lobe
* Requires more than a right or left trisegmentectomy
* At least 6 metastatic lesions distributed diffusely in both lobes of the liver
* Measurable disease

* At least 1 measurable lesion ≥ 20 mm
* No evidence of extrahepatic metastases by physical examination or x-ray
* No previously resected extrahepatic metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Hemoglobin ≥ 9 g/dL
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* AST ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ ULN
* No preexisting chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that would preclude surgical resection of metastases

Renal

* Creatinine ≤ 1.5 times ULN

Cardiovascular

* No myocardial infarction within the past 6 months
* No clinical evidence of congestive heart failure
* No New York Heart Association class III-IV heart disease
* No significant cardiac disease
* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No uncontrolled arrhythmias

Gastrointestinal

* Adequate oral nutrition with estimated caloric intake of ≥ 1,500 calories/day
* No severe anorexia or frequent nausea and/or vomiting
* No history of gastrointestinal bleeding that has not been appropriately addressed

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to tolerate major surgery
* No prior allergic reaction or known sensitivity to chimerized or murine monoclonal antibody therapy
* No documented presence of human anti-mouse antibodies
* No known allergy to other platinum compounds
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ, or tumors associated with less than 10% probability of death within 5 years of diagnosis
* No preexisting neuropathy ≥ grade 2
* No symptomatic pulmonary fibrosis or interstitial pneumonitis
* No uncontrolled bacterial or viral infection
* HIV negative
* No fungal infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No colony-stimulating factors within 24 hours of day 1 of each course
* No concurrent immunotherapy

Chemotherapy

* At least 1 year since prior adjuvant systemic fluorouracil with or without levamisole or with or without leucovorin calcium
* No prior oxaliplatin
* No prior systemic chemotherapy for metastatic disease
* No prior chemoembolization for metastatic disease
* No prior hepatic artery infusion chemotherapy for metastatic disease
* No other concurrent chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* At least 12 months since prior adjuvant radiotherapy
* Prior radiofrequency ablation allowed
* No prior radiotherapy to the liver
* No prior radiotherapy to more than 25% of the bone marrow
* No concurrent radiotherapy

Surgery

* See Disease Characteristics
* More than 21 days since prior abdominal exploration (with or without intestinal resection)

Other

* No prior anti-EGFR-directed therapy
* Prior cryotherapy allowed
* No oral cryotherapy on day 1 of each course

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R. Alberts, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Trinity Medical Center - East

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Bettendorf, Iowa, United States

Site Status