Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NCCTG-N014A NCT00056030, N014A

Objectives

1. Determine the surgical resectability rate of patients with unresectable hepatic metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin, fluorouracil, leucovorin calcium, and cetuximab.
2. Determine the response rate and overall survival of patients treated with this regimen.
3. Determine the quality of life of patients treated with this regimen.
4. Determine the toxicity of this regimen in these patients.

Entry 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

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

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/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

Outcomes

Surgical resectability rate as assessed by surgical resection of liver metastases

Response rate as measured by RECIST criteria every 6 weeks
Overall survival
Quality of life as assessed by UNISCALE and Symptom Distress Scale every 6 weeks

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		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
Trial Start Date		2004-12-03
Trial Completion Date		2006-11-23 (estimated)
Registered in ClinicalTrials.gov		NCT00056030
Date Submitted to PDQ		2003-01-28
Information Last Verified		2009-01-13
NCI Grant/Contract Number		CA25224

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