Open-label, phase II, multicentre study on cetuximab treatment asfirst-line monotherapy in elderly patients with metastatic colorectalcancer expressing EGFR

• Conditions: Epidermal Growth Factor Receptor-expressing in metatstatic colorrectal cancer in first line treatment.

• Registration Number: EUCTR2004-001696-19-ES
• Lead Sponsor: Spanish Cooperative Group for Gastrointestinal Tomour therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-01
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

·Written informed consent.
·Men and women >69 years.
·Histologically confirmed diagnosis of CRC.
·Non-resectable and/or non-operable metastatic colorectal carcinoma.
·Presence of at least one lesion by two-dimensional measurement; index lesions should not be in a region with previous irradiation.
·EGFR expression in the primary tumour and/or at least one of the metastases demonstrated by immunohistochemical analysis prior to study.
·Karnofsky functional status > 70% at the time of enrollment in the study.
·Life expectancy greater than 3 months.
·Patients will not have received chemotherapy for advanced/metastatic disease. ·Patients with the following characteristics will be included: 1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free interval > 12 months following conclusion of treatment. 2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment. 3. De novo diagnosis of disease.
·Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) £ 2.5 x ULN (£ 5 x ULN if there are hepatic metastases) and total bilirubin count < 1.5 x ULN.
·Proper kidney function, defined as serum creatinine < 1.5 x ULN.
·Proper hematological function, defined by neutrophil count >or= 1.5 x 109/l , platelets >or= 100 X 109/l and hemoglobin >or= 9 g/dl.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Documented or suspected cerebral and/or leptomeningeal metastases.
·Surgery (excluding biopsy for diagnosis) and /or radiotherapy during the 4 weeks prior to inclusion in the study.
·Participation in another clinical trial with medication in the past 30 days.
·Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy and any other investigational drug.
·Prior malignant tumor in the past 5 years, except for history of basal cell skin cancer or pre-invasive cervical cancer.
·Any investigational drug during the 4 weeks prior to inclusion.
·Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
·Prior participation in a study in which treatment with cetuximab may be assigned (whether or not treatment with cetuximab is received).
·Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.
·Evidence of grade 3 or 4 allergic reaction to any treatment components.
·Clinically relevant myocardial disease or history of infarction in the past 12 months.
·Known abuse of alcohol/drugs.
·Legal incapacity or limited legal capacity.
·Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
·Patients catalogued as delicate or frail” for compliance with any of the following criteria:Dependence in one or more activities of daily life according to the Katz Activity of Daily Living (ADL) scale,or 3 or more comorbid entities based on evaluation of the presence of the following processes: congestive heart failure; valvular heart disease; coronary artery disease; obstructive or restrictive chronic pulmonary disease; cerebrovascular disease; peripheral neuropathies; chronic renal failure; hypertension; diabetes; concomitant neoplasms; collagen vascular diseases; and incapacitating arthritis, or Presence of geriatric syndromes: moderate-severe dementia; delirium in situation of stress (urinary or respiratory infection, angina or drugs); moderate-severe depression that interferes with usual activity of patient; frequent falls (3 or more per month); lack of care (Who could help him or her in the event of an emergency?); urinary incontinence in the absence of stress, infection, diuretics or prostatic hyperplasia; fecal incontinence in the absence of diarrhea or laxatives; osteoporotic fractures of long bones or vertebral crush.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Confirmed objective response rate to cetuximab as first-line monotherapy.;Secondary Objective: ·Clinical benefit (objective response plus disease stabilization).<br>·Treatment safety.<br>·Time to progression and progression-free survival.<br>·Time to treatment failure.<br>·Duration of response.<br>·Overall survival.<br>·Determine time to onset of response.;Primary end point(s): Confirmed objective response rate