A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
It is generally accepted that the presence of chronically hypoxic cells, or tumor cells which
do not receive enough oxygen as a result of tumor growth, may be an important cause of
resistance to radiation therapy (RT) and resultant tumor recurrence, particularly in large
tumors such as advanced non-small-cell lung cancer (NSCLC). Therefore, delivering a higher RT
dose, as is done with hypofractionated RT, to the tumor may result in higher success rate.
Erlotinib (Tarceva, previously known as OSI-774) is an orally active, potent, selective
inhibitor of the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase. A recently
completed trial has shown that Erlotinib as a single agent significantly improves the
survival of patients with incurable Stage IIIb/IV NSCLC who have failed standard therapy for
advanced or metastatic disease. Therefore, Erlotinib is an approved medication for
second-line therapy in lung cancer following prior chemotherapy.
This is a Phase II clinical research study to assess the efficacy and toxicity of
hypofractionated radiation therapy in combination with Erlotinib in patients with locally
advanced or inoperable non-small-cell lung cancer (NSCLC).
The investigators' hypothesis is that the addition of erlotinib to RT will result in
radiosensitization, therefore increasing the likelihood of local tumor control over RT alone.
Maintenance erlotinib upon RT completion will result in further tumor growth inhibition, both
systemically and locally, lengthening disease-free survival and overall survival.
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University