| General information |
| Database: | DB00865 |
| Objective: | Erlotinib has shown activity in patients with brain metastases from non small cell lung cancer. The present doseescalationphase I trial evaluated the toxicity of whole brain radiotherapy (WBRT) with concurrent and maintenance erlotinib in this patient group. |
| Authors: | Lind JS, et al |
| Title: | Phase I study of concurrent whole brain radiotherapy and erlotinib for multiple brain metastases from non small cell lung cancer. |
| Journal: | Int J Radiat Oncol Biol Phys. |
| Year: | 2008 |
| PMID: | 19289264 |
| Trial Design |
| Clinical Trial Id: | NCT00536861 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | advanced cancer with brain metastasis |
| Cancer Subtype: | brain metastases from non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | doseescalationphase I trial |
| Key Patients Feature: | Patients with pathologically confirmed non small cell lung cancer and evidence of cerebral metastases on contrastenhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans were eligible for study enrollment |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Erlotinib (Cohort 1, 100 mg/d; Cohort 2, 150 mg/d) |
| Treatment Info: | Erlotinib (Cohort 1, 100 mg/d; Cohort 2, 150 mg/d) was started 1 week before, and continued during, WBRT (30 Gy in 10 fractions). Maintenance erlotinib (150 mg/d) was continued until unacceptable toxicity or disease progression |
| Primary End Point: | toxicity; |
| Secondary End Point: | overall survival and interval to progression |
| Patients Number: | 11 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | 141 days |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 133 days |
| Adverse Event(agent arm): | NA |
| Conclusions: | WBRT with concurrent erlotinib is well tolerated in patients with brain metastases from non small cell lung cancer. The suggestion of a high intracranial disease control rate warrants additional study. |