A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma
Data Collection
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: December 30, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone. Secondary * Compare the time to disease progression in patients treated with these regimens. * Compare the objective response rate in patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Compare the health utilities of patients treated with these regimens. * Conduct a comparative economic evaluation in patients treated with these regimens. * Determine the safety profile of cetuximab in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive an initial loading dose of cetuximab IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. Patients also receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible. * Arm II: Patients receive best supportive care as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalization for end-of-life care). Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 20 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.572 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Metastatic disease * Epidermal growth factor receptor (EGFR)-positive by immunochemistry * Measurable or evaluable disease * Not amenable to standard curative therapy * Best supportive care is the only available option * Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting * Combination therapy with oxaliplatin or irinotecan allowed * Must have failed\* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens * No symptomatic CNS metastases NOTE: \*Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * AST and ALT ≤ 5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No uncontrolled angina * No arrhythmias * No cardiomyopathy * No congestive heart failure * No myocardial infarction\* within the past 6 months NOTE: \*Pre-treatment ECG as only evidence of infarction is allowed Pulmonary * No severe restrictive lung disease * No interstitial lung disease by chest x-ray Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment * No active pathological condition that would preclude study participation * No psychological or geographical condition that would preclude study compliance * No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior cetuximab * No prior murine monoclonal antibody therapy (e.g., edrecolomab) Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * Concurrent palliative radiotherapy allowed except to index lesions Surgery * At least 4 weeks since prior major surgery and recovered Other * No prior EGFR-targeted therapy (e.g., erlotinib or gefitinib) * More than 30 days since prior experimental therapeutic agents * More than 4 weeks since prior investigational agents * No concurrent enrollment in another clinical study * No other concurrent EGFR-targeted therapy * No other concurrent non-cytotoxic experimental agents
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 33 locations
Cross Cancer Institute at University of Alberta
Edmonton, CanadaBritish Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, CanadaFraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, Canada