A randomised, placebo-controlled trial of Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer unsuitable for chemotherapy

ISRCTN ISRCTN77383050
DOI https://doi.org/10.1186/ISRCTN77383050
EudraCT/CTIS number 2004-000729-31
ClinicalTrials.gov number NCT00275132
Secondary identifying numbers N/A
Submission date
19/01/2004
Registration date
25/02/2004
Last edited
19/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-a-new-biological-therapy-for-advanced-non-small-cell-lung-cancer

Contact information

Dr Siow-Ming Lee
Scientific

Consultant Medical Oncologist
Meyerstein Institute of Oncology
Middlesex and UCL Hospitals
Mortimer Street
London
W1N 8AA
United Kingdom

Phone +44 (0)20 7380 9091
Email sm.lee@uclh.org

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised, placebo-controlled trial of Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer unsuitable for chemotherapy
Study acronymTOPICAL
Study objectivesErlotinib may stop the growth of tumour cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer (NSCLC).
Ethics approval(s)Multicentre Research Ethics Committee (MREC), 04/05/2004, ref: 04/6/032
Health condition(s) or problem(s) studiedNon-small cell lung cancer (NSCLC)
InterventionPatients are randomised to one of two treatment arms with 1:1 randomisation:
Arm 1: Tarceva (OSI-774, erlotinib) PO (by mouth) 150 mg daily up to 24 months.
Arm 2: Matched placebo PO daily up to 24 months
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Erlotinib
Primary outcome measureTo compare the effect on survival of Tarceva compared to placebo in patients with advanced NSCLC not suitable for chemotherapy.
Secondary outcome measures1. Progression free survival
2. Toxicity
3. Response rate
4. Quality of life
5. Cost-effectiveness
Overall study start date01/04/2005
Completion date31/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants664
Key inclusion criteria1. Diagnosis within 62 days prior to randomisation (this criteria was added on the 12th June 2007)
2. Histologically or cytologically confirmed NSCLC
3. Advanced disease NSCLC (stage IIIb or IV)
4. Chemotherapy-naive patients
5. Patients considered unsuitable for chemotherapy, for example:*
5.1. Eastern Cooperative Oncology Group (ECOG) performance status two or three
5.2. ECOG performance status zero or one with a calculated creatinine clearance less than or equal to 60 ml/min (Cockroft formula)
6. Aged 18 years or over
7. Estimated life expectancy of at least 8 weeks
8. Able to take oral medication
9. Using effective contraception if of reproductive potential (women of child bearing potential must have a negative pregnancy test performed by a healthcare professional prior to randomisation)
10. Willing and able to give informed consent
11. Willing to participate in the biological study

* examples given do not imply that all such patients are unsuitable for chemotherapy - patients should be considered individually
Key exclusion criteria1. Previous treatment with any biological anti-cancer therapy (e.g. Iressa, thalidomide, cetuximab)
2. Prior chemotherapy
3. Prior palliative radiotherapy (except to bone metastases, within the last 2 weeks)
4. Pregnant or lactating women
5. Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications. Examples include:
5.1. Severe uncontrolled infection
5.2. Cardiovascular: unstable angina, myocardial infarction within 1 month
5.3. Gastro-intestinal: uncontrolled inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)
5.4. Hepatic:
5.4.1. Serum bilirubin more than or equal to 2 x Upper Limit of Normal (ULN)
5.4.2. Serum transaminases more than or equal to 2 x ULN in the absence of liver metastases, or more than or equal to 5 x ULN with liver metastases
5.5. Renal:
5.5.1. Acute renal failure
5.5.2. Serum creatinine more than or equal to 5 x ULN
6. Other previous or current malignant disease likely to interfere with protocol treatment or comparisons
7. Symptomatic brain metastases
8. Current treatment with Cox II inhibitor
Date of first enrolment01/04/2005
Date of final enrolment31/01/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Middlesex and UCL Hospitals
London
W1N 8AA
United Kingdom

Sponsor information

University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C1438/A4147)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom
London Lung Cancer Group (UK) (Charity no. 1074994)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Plain English results No Yes
Results article results 01/11/2012 Yes No
Results article cost-effectiveness results 02/07/2015 Yes No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
11/01/2017: Internal Review
29/03/2016: Publication reference added.

On 12/06/2007 the overall trial end date was changed to 30/01/2009.