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 |
| ClinicalTrials.gov (NCT) | NCT00275132 |
| Clinical Trials Information System (CTIS) | 2004-000729-31 |
| Protocol serial number | N/A |
| Sponsor | University College London (UK) |
| Funders | Cancer Research UK (CRUK) (UK) (ref: C1438/A4147), London Lung Cancer Group (UK) (Charity no. 1074994) |
- 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
Contact information
Dr Siow-Ming Lee
Scientific
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 |
|---|---|
| sm.lee@uclh.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised, placebo-controlled trial of Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer unsuitable for chemotherapy |
| Study acronym | TOPICAL |
| Study objectives | Erlotinib 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) studied | Non-small cell lung cancer (NSCLC) |
| Intervention | Patients 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 type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Erlotinib |
| Primary outcome measure(s) |
To compare the effect on survival of Tarceva compared to placebo in patients with advanced NSCLC not suitable for chemotherapy. |
| Key secondary outcome measure(s) |
1. Progression free survival |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 664 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/04/2005 |
| Date of final enrolment | 31/01/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Middlesex and UCL Hospitals
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | Yes | No | |
| Results article | cost-effectiveness results | 02/07/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
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.
