Colorectal Cancer (CRC) Cetuximab Elderly Frail

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetuximab; Fluorouracil; Leucovorin

Criteria

Inclusion Criteria:

• Pathologically confirmed metastatic colorectal cancer

• Measurable disease according to RECIST V1.1

• Histological local review and analysis of KRAS

• Age ≥ 80 or ≥ 70 in combination with functional restrictions defined as limitation in at least 2 of 8 IADL

• WHO performance status 0, 1 or 2

• Adequate bone marrow reserves, hepatic function & renal function

• Normal 12 lead ECG without clinically significant abnormalities

• Written informed consent before randomization according to ICH/EU GCP, and local, national and international regulations

Exclusion Criteria:

• Prior systemic chemotherapy for metastatic disease

• Previous exposure to EGFR or VEGF/VEGFR targeted therapy

• Patients may have received chemotherapy in the adjuvant or neoadjuvant setting (CRC). The treatment-free interval should be 6 months or more from the end of (neo-)adjuvant therapy

• 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

• Persistence of clinically relevant treatment-related toxicities from previous chemotherapy and/or radiotherapy (adjuvant or neo-adjuvant setting)

• 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

• Known alcohol or drug abuse

• Clinically significant cardiovascular disease

• Evidence of uncontrolled medical comorbidities despite adequate treatment

• Patients who have suffered a cerebrovascular accident or transient ischemic attack within the past 12 months

• History, within the past 5 years, of malignancies other than CRC

• Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and followup schedule