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A Phase I Study of Radiotherapy Concurrent With Erlotinib (Tarceva®) in the Treatment of Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
Not Enrolling
Non-Small Cell Lung Cancer, Brain Metastases

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Trial Information

A Phase I Study of Radiotherapy Concurrent With Erlotinib (Tarceva®) in the Treatment of Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Histological or cytological confirmation of non-small cell lung cancer (NSCLC)

- Diagnosis of brain metastases on a contrast-enhanced CT scan or Gadolinium-enhanced

- Patients who are not candidates for surgery or stereotactic radiosurgery

- RPA Class 1 or 2 (Karnofsky performance status > 70)

- Age > 18 years

- No previous radiotherapy, surgery or chemotherapy for brain metastases

- Patients must be able to take oral medication.

- Patients should not have any unstable systemic disease except lung cancer (including
active infection, uncontrolled hypertension, unstable angina, congestive heart
failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic

- Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L OK

- Serum bilirubin must be < 1.5 upper limit of normal (ULN).

- AST and/or ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis)

- Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min

- Patients with reproductive potential must use effective contraception. For all
females of childbearing potential a negative pregnancy test must be obtained within
72 hours before starting therapy.

- Able to comply with study and follow-up procedures

- Written informed consent.

Exclusion Criteria:

- Any unstable systemic disease (including active infection, grade 4 hypertension,
unstable angina, congestive heart failure, hepatic, renal or metabolic disease).

- Signs, symptoms or MRI findings consistent with leptomeningeal metastases.

- Concomitant use of phenytoin anticonvulsant medication

- Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small
molecule or monoclonal antibody therapy).

- Any other malignancies in the preceding 5 years (except for adequately treated
carcinoma in situ of the cervix or basal or squamous cell skin cancer).

- Any significant ophthalmological abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions. The use of
contact lenses is not recommended during the study. The decision to continue to wear
contact lenses should be discussed with the patient's treating Oncologist and

- Patients who cannot take oral medication, who require intravenous alimentation, have
had prior surgical procedures affecting absorption, or have active peptic ulcer

- Nursing mothers.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the safety of concurrent palliative whole brain radiotherapy and two doses of erlotinib in patients with brain metastases from NSCLC

Outcome Time Frame:

Until death

Safety Issue:


Principal Investigator

Suresh Senan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

VU University Medical Center


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

VUMC 2005/177



Start Date:

May 2006

Completion Date:

December 2007

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Brain Metastases
  • erlotinib
  • cranial radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms