Erlotinib and Stereotactic Body Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Non-Small Call Lung Cancer
Recruitment status was: Recruiting
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with stereotactic body radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic body radiation therapy works in treating patients with locally advanced or metastatic non-small cell lung cancer.
Drug: erlotinib hydrochloride
Radiation: stereotactic body radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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)|
- 6-month progression-free survival [ Designated as safety issue: No ]
- Rate of in-field local control and out-of-field disease progression [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Duration of erlotinib use and time to initiation of third-line systemic therapy [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547105
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Study Chair:||Robert D. Timmerman, MD||Simmons Cancer Center|