Status:
TERMINATED
Colorectal Cancer (CRC) Cetuximab Elderly Frail
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief 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)...
Detailed Description
The primary efficacy analyses will be performed on the Intention-to-treat population. The safety analyses will be performed on the Safety population. * Median PFS and OS in each treatment arm with i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01522612
Start Date
April 1 2013
End Date
January 1 2015
Last Update
June 10 2016
Active Locations (3)
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1
AZ Turnhout - Campus Sint Elisabeth
Turnhout, Belgium
2
Bank Of Cyprus Oncology Centre
Nicosia, Cyprus
3
Hospital General Vall D'Hebron
Barcelona, Spain