Advanced non-small cell lung cancer with multiple brain metastases
Conditions
Interventions
Trade Name: Tarceva 25 mg, 100 mg & 150 mg
Product Name: Tarceva
Product Code: OSI-774
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administr
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Histologically or cytologically confirmed NSCLC. A biopsy of metastatic disease in the brain is not required for study enrolment. b) Patients with newly diagnosed single or multiple brain metastases in whom immediate chemotherapy is not required for palliation of systemic extra-cranial disease. Patients with a solitary brain metastasis are only eligible for the trial providing they are not suitable for stereotactic radiotherapy or surgical resection. c) Diagnosis of brain metastases must be confirmed on MRI or contrast CT scan. d) Able to start treatment within 4 weeks of the baseline measurement scans of the brain, chest & abdomen. e) Patients with post-craniotomy incomplete resection will be permitted. f) No prior cranial radiotherapy. g) = 28 days from any chemotherapy to Day 1 of trial treatment. h) Clinician certain of the role of WBRT. i) Glasgow Coma Score =14. j) Karnofsky performance status = 70, RTOG RPA class I and II (modified by age to 18 years and 40ml/min, absence of evidence of acute renal failure. m) Adequate liver function, ALT or AST =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Presence of a solitary brain metastasis suitable for stereotactic radiosurgery or surgical resection. b) Patients who require immediate chemotherapy for symptom control. c) Clinician certain that WBRT will NOT be of benefit. d) Clinician uncertain of the role of WBRT. e) Previous treatment with any EGFR anti-cancer therapy (e.g. Tarceva, Iressa or Cetuximab). f) Previous treatment for brain metastases (radiosurgery, radiotherapy or chemotherapy) - however prior radiotherapy or surgery to the primary tumour and/or systemic treatment to metastatic sites of disease is acceptable. g) Glasgow Coma Score 75 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effect on neurological progression-free survival at 2 months (n = neurological progression or death) of WBRT, with concomitant Tarceva compared to WBRT alone in patients with advanced NSCLC with multiple brain metastases;Secondary Objective: (i) Toxicity (ii) Response rate (iii) Quality of life (iv) Change in Performance Status (v) Steroid dosing (vi) Sites of progression (cranial or extracranial) will also be recorded. ;Primary end point(s): Neurological progression-free survival at 2 months | — |
Countries
United Kingdom
Outcome results
None listed