Erlotinib and Stereotactic Body Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Non-Small Call Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00547105|
Recruitment Status : Unknown
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 22, 2007
Last Update Posted : June 23, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: erlotinib hydrochloride Radiation: stereotactic body radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|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)|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||July 2010|
- 6-month progression-free survival
- Rate of in-field local control and out-of-field disease progression
- Overall survival
- Duration of erlotinib use and time to initiation of third-line systemic therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547105
|United States, Colorado|
|University of Colorado Cancer Center at UC Health Sciences Center||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Clinical Trials Office - University of Colorado Cancer Center 720-848-0650|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097|
|Study Chair:||Robert D. Timmerman, MD||Simmons Cancer Center|