Trial of cetuximab for colorectal cancer in elderly and frail patients.

Phase 1

• Conditions: Metastatic Colorectal Cancer; MedDRA version: 14.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002947-83-BE
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-19
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1) Male or female patients with pathologically confirmed KRAS WT mCRC
2) Measurable disease according to RECIST V1.1, patients with not measurable disease will be reviewed by the study coordinator and EORTC HQ, the study sponsor
3) No prior systemic chemotherapy for metastatic disease
4) No previous exposure to EGFR or VEGF/VEGFR targeted therapy
5) Patients may have received chemotherapy in the adjuvant or neo-adjuvant setting for CRC. The treatment-free interval should be 6 months or more from the end of (neo-)adjuvant therapy
6) Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields
7) No persistence of clinically relevant treatment-related toxicities from previous chemotherapy and/or radiotherapy (adjuvant or neo-adjuvant setting)
8) No treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial
9) Age = 80 or = 70 in combination with functional restrictions defined as limitation in at least 2 of 8 Instrumental Activities of Daily (IADL) Living as described in the protocol
10) WHO performance status 0, 1 or 2
11) Adequate bone marrow reserves: absolute neutrophil count =1.5 x 109 cells/L, platelets =100 x 109 cells/L and uncorrected hemoglobin =10g/dL (i.e., without blood transfusion or use of erythropoietin)
12) Adequate hepatic function: either AST or ALT = 2.5x ULN (in presence of liver metastases, either AST or ALT = 5x ULN), total bilirubin <1.5x ULN
13) Adequate renal function: GFR > 60 ml/min as measured by Modification of Diet in Renal Disease formula before receiving chemotherapy
14) Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable, except for GFR.
15) Normal 12 lead ECG without clinically significant abnormalities
16) Written informed consent before randomization according to ICH/EU GCP, and local, national and international regulations.
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1) Alcohol or drug abuse
2)Clinically significant cardiovascular disease:
-Uncontrolled hypertension
-New York Heart Association class II-IV congestive heart failure
-Unstable angina pectoris within the past 12 months.
-Peripheral vascular disease = grade 2
-Serious cardiac arrhythmia requiring medication
-Myocardial infarction within the past 12 months
-Clinically significant cardiovascular disease
3) Evidence of uncontrolled medical comorbidities despite adequate treatment (according to treating physician) like :
-Chronic Obstructive Pulmonary Disease (COPD)
_Serious infections requiring systemic antibiotic therapy (e.g. antimicrobial, antifungal, antiviral)
4) Patient who has suffered a cerebrovascular accident or transient ischemic attack within the past 12 months.
5) History, within the past five years, of malignancies other than CRC (except: adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score = 6 and postoperative PSA < 0.5 ng/ml). Patients with any history of malignancies who are disease-free for more than 5 years are eligible.
6) Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, those conditions should be discussed with the patient before registration in the trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-FU regimen in elderly/frail patients with KRAS wild type (WT) metastatic colorectal cancer (mCRC) prolongs progression free survival (PFS), compared with 5-FU alone.;Secondary Objective: NOT APPLICABLE;Primary end point(s): The primary end-point is PFS. Progression will be defined according to the RECIST V1.1”.<br>;Timepoint(s) of evaluation of this end point: At baseline, six weeks and then every eight weeks until progressive disease