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)
This study is a single arm phase II pilot trial. Enrollment of 24 patients nationwide is expected, with 20 patients recruited from UT Southwestern and its affiliates. Patients enrolled on the trial will have received or will begin to receive Tarceva at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of Tarceva and will be given according to guidelines outlined in Section 4 of the protocol. The anticipated length of participation is approximately 4 years with 14 office visits. These office visits are standard of care and research information will be collect at visit. Maintenance Tarceva will continue until disease progression uncontrollable by SBRT, intolerable toxicity, or death
• Patients must have biopsy proven NSCLC that is locally advanced or metastatic.
• Patients must have had failure of at least one prior chemotherapy regimen.
• Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.
• Age ≥ 18 years
• Patients must have measurable disease at baseline.
• Patients can have up to only 6 discrete (as in can be seen on film, CT or MRI) active (as in can be detected by PET) 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.
o 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
o 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.
o Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
o Up to 2 contiguous vertebral metastases will be considered a single site of disease.
• Patients must have a KPS >60
• AST, ALT & Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
• Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
• Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
• Females of childbearing potential should have a negative pregnancy test.
• 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.
• Patients must provide verbal and written informed consent to participate in the study.
• Total bilirubin: within normal institutional limits