A phase I/II randomised study of Tarceva® (erlotonib), used concurrently with thoracic radiation in patients with advanced non-small cell lung cancer

ISRCTN ISRCTN92263269
DOI https://doi.org/10.1186/ISRCTN92263269
Secondary identifying numbers MAST1006
Submission date
13/10/2008
Registration date
16/01/2009
Last edited
13/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Mangar
Scientific

Department of Radiotherapy
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Study information

Study designPhase I: Interventional open-label single-centre trial Phase II: Open-label randomised controlled multi-centre 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 to request a patient information sheet
Scientific titleTarceva® (erlotonib), used concurrently with thoracic radiation in patients with advanced non-small cell lung cancer: a phase I/II open-label randomised controlled trial
Study acronymTACTICAL
Study objectivesTo explore the use of concurrent radiotherapy and an oral tablet called erlotinib (an epidermal growth factor inhibitor) for the treatment of advanced non-small cell lung cancer and assess whether combination therapy improves response and overall survival compared to radiotherapy alone.
Ethics approval(s)West Midlands Research Ethics Committee, approval pending as of 13/10/2008, ref: 08/H1208/41
Health condition(s) or problem(s) studiedNon-small cell lung cancer (NSCLC)
InterventionPhase I: All 18 patients will receive erlotonib 150 mg orally (po) once daily. This will be combined with radiotherapy consisting of an initial radiation dose of 30 Gy/10 factions (3 Gy, 5 days per week, 2 weeks) for the first 6 patients, with a view to dose escalation to 36 Gy/12 fractions with two further groups of 6 patients depending on observed dose limiting toxicity levels.

Phase II: Radiotherapy will be administered to all patients at the optimal dose determined in Phase 1 - either 30 Gy/10 fractions or 36 Gy/12 fractions. Half of patients will also receive erlotinib 150 mg po, once daily. Erlotinib and follow-up will continue after the radiotherapy until disease progression or the development of grade 3 or 4 toxicity despite dose reduction.

Follow-up: Each subject is followed for 12 weeks including pre-treatment and treatment visits, then monthly for 6 months if there is no progression and then annually until progression.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Erlotonib (Tarceva®)
Primary outcome measurePhase I: Evaluation of early safety and efficacy of erlotinib by determining the maximum tolerated dose in combination with external beam radiotherapy
Phase II: Evaluation of disease control rate at 6 months
Secondary outcome measures1. Objective response rate, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) at baseline, 6 weeks after radiotherapy treatment (Visit 9, Week 9) and 6 months.
2. Duration of response
3. Time to progression
4. Time to distant failure
5. Overall survival
6. Safety
Overall study start date01/01/2009
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participantsPhase I: 18; Phase II: 80 (total: 98)
Key inclusion criteriaPatients (both males and females) with non-small cell lung cancer (NSCLC) with:
1. Histologically or cytologically confirmed non-small cell lung cancer
2. Unresectable stage III or metastatic disease suitable for fractionated palliative radiotherapy
3. One dimensionally measurable disease
4. No prior radiotherapy for this cancer
5. Forced expiratory volume in 1 second (FEV1) >1
6. Performance status less or equal to 2
7. Adequate haematologic function
8. Serum creatinine concentration >1.5 x upper limit or normal (ULN) and /or EDTA clearance >60 ml/min
9. Bilirubin level <1.5 x ULN
10. Age 18-80 years
11. Females of child bearing potential must agree to comply with effective contraceptive measures
Key exclusion criteriaPatients with non-small cell lung cancer must not meet any of the following:
1. Previous radiotherapy for non-small cell lung cancer
2. Concurrent treatment with other experimental drugs
3. Past or current history of other neoplasms, except a) curatively treated non-melanoma skin cancer or b) adequately treated in-situ cancer of the cervix or c) other cancer curatively treated and with no evidence of disease for at least 5 years
4. Significant cardiac disease, clinical congestive cardiac failure, cardiac arrhythmia, uncontrolled hypertension or recent history of myocardial infarction/ischaemia
5. Serious intercurrent medical or psychiatric illness, including serious active infection
6. Pregnant or nursing women
Date of first enrolment01/01/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Hammersmith Hospital
London
W12 0HS
United Kingdom

Sponsor information

Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre

c/o Dr Rodney Gale
Hammersmith House
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom

Phone +44 (0)20 8383 3329
Email rodney.gale@imperial.nhs.uk
Website http://www.imperial.nhs.uk
ROR logo "ROR" https://ror.org/056ffv270

Funders

Funder type

Industry

Roche Products Limited (UK) (ref: MO21781)

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?
HRA research summary 28/06/2023 No No

Editorial Notes

13/10/2017: No publications found, verifying study status with principal investigator.