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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2004

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A Phase II Study Of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), Leucovorin (CF), and Cetuximab (C225) For Patients With Unresectable Hepatic Metastases From Metastatic Adenocarcinoma Of The Colon Or Rectum

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.

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.

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
We found this trial at
162
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Kewanee, Illinois 61443
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Kewanee, IL
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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397
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1920 Libal Street
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(920) 433-8889
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
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746
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825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
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784
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777 Kimole Ln
Adrian, Michigan 49221
517-265-0900
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143
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745
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Alexandria, MN
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Anderson, South Carolina 29621
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Anderson, SC
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Aurora, Illinois 60507
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Aurora, IL
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
(317) 528-5000
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1233 34th St NW
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405
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500 N 8th St
Bismarck, North Dakota 58501
(701) 222-6100
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400 E Third Street
Duluth, Minnesota 55805
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700 West Central
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Escanaba, Michigan 49431
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101 S Major St
Eureka, Illinois 61530
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820 4th Street North
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801 Broadway N
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200 West Pearl Street
Findlay, Ohio 45840
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Fremont, Ohio 43420
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550 Osborne Road
Fridley, Minnesota 55432
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Galesburg, Illinois 61401
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3315 N. Seminary Street
Galesburg, Illinois 61401
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960 S. Columbia Rd.
Grand Forks, North Dakota 58201
701-780-5400
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1117 29th St S Ste 500
Great Falls, Montana 59405
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615 N. Promenade Street
Havana, Illinois 62644
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Hopedale, Illinois 61747
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1095 Minnesota 15
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1721 S Stephenson Ave
Iron Mountain, Michigan 49801
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Jacksonville, Florida 32216
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750 Avenue D West
Kingman, Kansas 67068
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Lichfield, Minnesota 55355
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1001 Bellefontaine Ave
Lima, Ohio 45804
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Macomb, Illinois 61455
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Maplewood, Minnesota 55109
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Marinette, Wisconsin 54143
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301 W Homer St
Michigan City, Indiana 46360
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800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
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Minneapolis, Minnesota 55415
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Mobile, Alabama 36607
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800 Stewart Rd
Monroe, Michigan 48162
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720 Medical Center Drive
Newton, Kansas 67114
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1304 Franklin Avenue
Normal, Illinois 61761
309.454.1400
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Oconto Falls, Wisconsin 54154
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6901 N 72nd St
Omaha, Nebraska 68122
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Omaha, Nebraska 68124
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601 N 30th St
Omaha, Nebraska 68131
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Oregon, Ohio 43616
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2600 Navarre Ave
Oregon, Ohio 43616
(419) 578-7555
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Ottawa, IL
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