Contact information
Type
Scientific
Primary contact
Ms Lynnda Peachey
ORCID ID
Contact details
COG Trial Co-ordinator
Oncology Clinical Trials Office (OCTO)
Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
off Roosevelt Drive
Headington
Oxford
OX3 7DQ
United Kingdom
+44 (0)1865 617016
lynnda.peachey@clinpharm.ox.ac.uk
Additional identifiers
EudraCT number
2007-005391-13
ClinicalTrials.gov number
NCT01243398
Protocol/serial number
OCTO_005
Study information
Scientific title
Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy
Acronym
COG
Study hypothesis
That gefitinib (Iressa®) 500 mg once daily will halt/slow the progression of oesophageal adenocarcinoma and squamous cancers, and thereby improve the survival of patients with these cancers.
As of 15/02/2011 the anticipated end date for this trial has been updated from 01/09/2010 to 30/09/2011.
Ethics approval
Added 26/10/09: Multicentre Research Ethics Committee (MREC) approved 20/10/2008
Study design
National multi-centre phase III randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Oesophageal cancer
Intervention
450 (225 per arm) patients will be randomised to either Gefitinib 500 mg (Iressa®) or placebo.
As of October 2009: recruiting
Duration of the interventions: The trial will close 6 months after the end of recruitment or when 389 events have occurred.
Intervention type
Drug
Phase
Not Specified
Drug names
Gefitinib (Iressa®)
Primary outcome measure
Overall survival, assessed at each visit (every 4 weeks) or in-between if death is reported to site by family/friends until the end of trial.
Secondary outcome measures
1. Toxicity of gefitinib monotherapy in oesophageal cancer patients, assessed through Adverse Events (AE) and Serious Adverse Events (SAE) reporting (assessed at each visit or in between when reported by patients/family)
2. Quality of life, assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-OES18 at baseline, 4 weeks, 8 weeks and 12 weeks
3. Time to clinical or radiological progression, assessed by the following:
3.1. Examination by medical staff at each visit
3.2. CT Scans (chest and abdomen) at baseline, 4, 8 and 16 weeks and then every 8 weeks until the end of trial
3.3. Chest X-rays at baseline, 4, 8, 12 and 16 weeks and then every 8 weeks until the end of trial
4. Identification of genetic signature associated with benefit, via blood samples and tissue taken at biopsy using Deoxyribonucleic Acid (DNA) microarray technology to identify genes associated with response and prognosis. Please note that this will be done by HANDEL (a translational research project) which will run in parallel to the COG Trial as a separate protocol
Overall trial start date
01/03/2009
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Prior to 26/10/09:
1. Aged greater than 18 years
2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
3. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease
4. Creatinine clearance greater than 30 ml/min; alkaline phosphatase, bilirubin and Alanine aminotransferase (ALT) less than 2 x Upper Limit of Normal (ULN); haemoglobin greater than 10 g/dL
5. World Health Organization (WHO) performance Status 0, 1 or 2
6. Measurable or evaluable disease by Computerised Tomography (CT) scan
7. Able to swallow tablets
8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry
9. Patients must complete the Quality Of Life (QOL) baseline questionnaire
Amended 26/10/09:
1. Aged greater than 18 years
2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
3. Histologically proven adenocarcinoma, squamous cell cancer or poorly differentiated epithelial malignancy
4. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease [date of last administration of chemotherapy must be >6 weeks prior to randomisation]
5. World Health Organization (WHO) performance Status 0, 1 or 2
6. Measurable or evaluable disease by Computerised Tomography (CT) scan
7. Able to swallow tablets
8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
450
Participant exclusion criteria
Prior to 26/11/09:
1. Previous malignancy not treated curatively
2. Previous malignancy treated curatively less than 5 years ago
3. Medical condition considered to interfere with the safe participation in the trial
4. Radiotherapy to site of measurable or evaluable disease in the last month
5. Pregnancy
6. Not able to give written informed consent
Amended 26/101/09:
1. Presence of previous or other malignancy likely to confound results or interfere with gefitinib therapy
2. Medical condition considered to interfere with the safe participation in the trial
3. Radiotherapy to site of measurable or evaluable disease in the last 4 weeks
4. Pregnancy
5. Sexually active patients of child-bearing potential not using adequate contraception* (male and female) [post menopausal women must have been amenorrheic for at least 12 months to be considered as having non-child-bearing potential]
6. Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)
7. Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
8. Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
9. Known severe hypersensitivity to gefitinib or any of the excipients of this product
10. On other cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications
* For female trial participants: birth control pills, approved contraceptive implant, spermicidal foam and condoms, intrauterine device, or prior tubal ligation. For male trial participants: condoms and spermicidal foams or prior vasectomy.
Recruitment start date
01/03/2009
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
COG Trial Co-ordinator
Oxford
OX3 7DQ
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Oncology Clinical Trials Office (OCTO)
Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
off Roosevelt Drive
Headington
Oxford
OX3 7DQ
United Kingdom
-
heather.house@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK) - main funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Astra Zeneca (UK) - Supplying trial medication (Gefitinib) and placebo
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24950987
Publication citations
-
Results
Dutton SJ, Ferry DR, Blazeby JM, Abbas H, Dahle-Smith A, Mansoor W, Thompson J, Harrison M, Chatterjee A, Falk S, Garcia-Alonso A, Fyfe DW, Hubner RA, Gamble T, Peachey L, Davoudianfar M, Pearson SR, Julier P, Jankowski J, Kerr R, Petty RD, Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial., Lancet Oncol., 2014, 15, 8, 894-904, doi: 10.1016/S1470-2045(14)70024-5.