Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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.
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Checked against the public recordLast updated Aug 21, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- University of Texas Southwestern Medical Center
- Interventions being studied
- Drug: Erlotinib; Radiation: SBRT
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Patients must have biopsy proven NSCLC that is locally advanced or metastatic. 2. Patients must have had failure of at least one prior chemotherapy regimen. 3. Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT. 4. Age ≥ 18 years 5. Patients must have measurable disease at baseline. 6. Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by PET scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of SBRT. 1. For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months 2. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months. 3. Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2). 4. Up to 2 contiguous vertebral metastases will be considered a single site of disease. 7. Patients must have a KPS \>60 8. AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal. 9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³. 10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN). 11. Females of childbearing potential should have a negative pregnancy test. 12. Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L. 13. Patients must provide verbal and written informed consent to participate in the study. 14. Total bilirubin: within normal institutional limits
Patients who meet any of the following
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2020. Always confirm current availability with the study team.