Colorectal Cancer (CRC) Cetuximab Elderly Frail

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Terminated

Phase 2

Conditions

Colorectal Cancer Metastatic

Treatments

Drug: Cetuximab

Drug: 5-fluorouracil

Drug: leucovorin

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01522612

EORTC-40085-75083

2011-002947-83 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 its 95% CI, estimated by the Kaplan-Meier technique
Response rates by treatment arm with their exact 95% CI
IADL sum score, G8 sum score and social situation by treatment arm at baseline and at each timepoint of assessment
QoL scores from the EORTC QLQ-C30 and QLQ-ELD14 modules by treatment arm at baseline and at each timepoint of assessment
Safety data by treatment arm in the Safety population. Worst toxicity grade over all cycles according to the CTCAE criteria version 4.0 by treatment arm.
Pharmaco-economics evaluation

Summary of proposed Phase II trial characteristics:

Total number of randomized patients: 150.
Total number of events at phase II analysis for primary endpoint: 110.
Total number of patients screened over the phase II: 250.
Total number of patients treated with cetuximab for the Phase II study: 75.
Maximum study duration: 19 months.

In the present study, HRQoL is an important secondary endpoint. The objective of the HRQoL data collection in this Phase II trial is to assess the impact of the addition of cetuximab on patients' HRQoL during treatment.

The hypothesis is that there will be no difference in patients' HRQoL between both treatment arms during treatment. The HRQoL domains (from the EORTC QLQ-C30 module) which are expected to be affected by treatment (to the same extent in both arms) are Global health status, Fatigue, Pain and Stool habits.

Enrollment

5 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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