Overview

This trial is active, not recruiting.

Conditions colorectal cancer, metastatic cancer
Treatments cetuximab, fluorouracil, leucovorin calcium, oxaliplatin
Phase phase 2
Target EGFR
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date December 2004
End date March 2008
Trial size 73 participants
Trial identifier NCT00056030, CDR0000271923, NCCTG-N014A, NCI-2012-02521

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cetuximab
fluorouracil
leucovorin calcium
oxaliplatin

Primary Outcomes

Measure
Surgical resectability rate as assessed by surgical resection of liver metastases
time frame: Up to 4 years

Secondary Outcomes

Measure
Response rate as measured by RECIST criteria every 6 weeks
time frame: Up to 4 years
Overall survival
time frame: Up to 4 years
Quality of life as assessed by UNISCALE and Symptom Distress Scale every 6 weeks
time frame: Up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.