Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MAST1006
Study information
Scientific title
Tarceva® (erlotonib), used concurrently with thoracic radiation in patients with advanced non-small cell lung cancer: a phase I/II open-label randomised controlled trial
Acronym
TACTICAL
Study hypothesis
To 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
West Midlands Research Ethics Committee, approval pending as of 13/10/2008, ref: 08/H1208/41
Study design
Phase I: Interventional open-label single-centre trial
Phase II: Open-label randomised controlled multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Non-small cell lung cancer (NSCLC)
Intervention
Phase 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 type
Drug
Phase
Not Applicable
Drug names
Erlotonib (Tarceva®)
Primary outcome measure
Phase 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 measures
1. 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 trial start date
01/01/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Phase I: 18; Phase II: 80 (total: 98)
Participant exclusion criteria
Patients 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
Recruitment start date
01/01/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
Sponsor information
Organisation
Imperial College Healthcare NHS Trust (UK)
Sponsor details
c/o Dr Rodney Gale
Hammersmith House
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 3329
rodney.gale@imperial.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Roche Products Limited (UK) (ref: MO21781)
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