Colorectal Cancer (CRC) Cetuximab Elderly Frail

NCT01522612 | Terminated Phase 2 DMC

• 2 other identifiers: EORTC-40085-750832011-002947-83
• Study Type: interventional
• Target: 5
• Locations: 3 countries
• Sites: 3

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) prolongs Progression Free Survival, compared with 5-fluorouracil alone.

Conditions

Colorectal Cancer Metastatic

Keywords

KRAS Wild Type; Frail Elderly; QLQ-C30; QLQ-ELD14; CGA; EGFR; Cetuximab; 5-FU

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression will be defined according to the "RECIST V1.1"

  19 months from first patient in

Secondary Outcomes (11)

• Overall Survival

  19 months from first patient in

• Response Rate

  19 months from first patient in

• Change in Instrumental Activities of Daily Living (IADL) score

  19 months from first patient in

• Change in G8 geriatric assessment screening tool

  19 months from first patient in

• Change in social situation

  19 months from first patient in

Study Arms (2)

5-fluorouracil/leucovorin plus cetuximab

EXPERIMENTAL

Drug: Cetuximab; Drug: 5-fluorouracil; Drug: leucovorin

5-fluorouracil/leucovorin alone

ACTIVE COMPARATOR

Drug: 5-fluorouracil; Drug: leucovorin

Interventions

Cetuximab DRUG

500 mg/m2 on day 1, Every 14 days Intravenously

Also known as: Erbitux

5-fluorouracil/leucovorin plus cetuximab

5-fluorouracil DRUG

Every 2 weeks, 400 mg/m2 on day 1; 2400 mg/m2 from day 1 to day 3, intravenously

Also known as: 5-FU

5-fluorouracil/leucovorin alone; 5-fluorouracil/leucovorin plus cetuximab

leucovorin DRUG

Every 2 weeks, Racemic leucovorin 200 mg/m2 or l-leucovorin 100 mg/m2 on day 1, intravenously

Also known as: Folinic Acid

5-fluorouracil/leucovorin alone; 5-fluorouracil/leucovorin plus cetuximab

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (3)

AZ Turnhout - Campus Sint Elisabeth

Turnhout, Belgium

Location

Bank Of Cyprus Oncology Centre

Nicosia, Cyprus

Location

Hospital General Vall D'Hebron

Barcelona, Spain

Location

Related Links

• Related Info

MeSH Terms

Interventions

Cetuximab; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Marc Peeters, MD, PhD

  UNIVERSITAIR ZIEKENHUIS ANTWERPEN, Edegem, Belgium

  STUDY CHAIR

• Ulrich Wedding, MD

  UNIVERSITAETSKLINIKUM JENA, Jena, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: January 31, 2012
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

ES (1); CY (1); BE (1)