A Phase II Trial of Erlotinib (Tarceva®) in Combination With Stereotactic Body Radiation Therapy (SBRT) for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
OBJECTIVES:
Primary
- To evaluate the effect of erlotinib and stereotactic body radiotherapy on 6-month
progression-free survival of patients with locally advanced or metastatic non-small
cell lung cancer.
Secondary
- To describe the actuarial rate of in-field local control and out-of-field disease
progression in patients treated with this regimen.
- To evaluate the safety of this regimen in these patients.
- To evaluate overall survival of patients treated with this regimen.
- To evaluate the duration of erlotinib usage and time to initiation of third-line
systemic therapy (chemotherapy or biologic agent) in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily in the absence of disease
progression or unacceptable toxicity. Beginning 1-4 weeks after the initiation of erlotinib
hydrochloride, patients undergo stereotactic body radiotherapy.
After completion of study treatment, patients are followed every 3 months.
Interventional
Primary Purpose: Treatment
6-month progression-free survival
No
Robert D. Timmerman, MD
Study Chair
Simmons Cancer Center
Unspecified
CDR0000571634
NCT00547105
June 2007
Name | Location |
---|---|
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |