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)
Overview
- Phase
- Phase 2
- Intervention
- Erlotinib
- Conditions
- Lung Cancer
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- 6 Month Progression-Free Survival
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
erlotinib in combination with SBRT
Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib
Intervention: Erlotinib
erlotinib in combination with SBRT
Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib
Intervention: SBRT
Outcomes
Primary Outcomes
6 Month Progression-Free Survival
Time Frame: 6 months
For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.
Secondary Outcomes
- Overall Survival(up to 5 years)
- Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy(3 years)
- Out-of-field Disease Progression(9 months)
- In-field Local Control(9 months)
- Number of Participants Without Serious Adverse Events Related to Radiation(3 years)
- Progression-free Survival(up to 5 years)