Non-small cell lung cancer (NSCLC) Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
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 we
Sponsors
Imperial College Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed