Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; SBRT
Intervention description: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.; SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This study is a single arm phase II pilot trial. 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. Maintenance erlotinib will continue until disease progression uncontrollable by SBRT, intolerable toxicity, or death.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; stage IIIA non-small cell lung cancer

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.
    

Eligibility criteria:

        Inclusion Criteria

        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

        Exclusion Criteria Patients who meet any of the following exclusion criteria are not to be
        enrolled in this study.

          1. Patients who previously received radiotherapy to the primary site with CT evidence of
             disease progression at the primary site within 3 months following the initial
             radiotherapy.

          2. Patients with either untreated brain metastases or brain metastases treated within the
             past three months are ineligible

          3. Patients with serious, uncontrolled, concurrent infection(s).

          4. Significant weight loss (>10%) in the prior 3 months.

          5. Because the tolerance dose of SBRT to the gastrointestinal tract is not established,
             patients with metastatic disease invading the esophagus, stomach, intestines, or
             mesenteric lymph nodes will not be eligible.

          6. Patients with cutaneous metastasis of NSCLC.

          7. Treatment for other carcinomas within the last five years, except cured non-melanoma
             skin and treated in-situ cancers.

          8. Patients with more than 6 discrete extra-cranial lesions.

          9. Participation in any investigational drug study within 4 weeks preceding the start of
             study treatment.

         10. Unwillingness to participate or inability to comply with the protocol for the duration
             of the study.

         11. Patients who are pregnant. Patients with reproductive capability will need to use
             adequate contraception during the time of participation in the study.

         12. Patients who have had prior EGFR inhibitors.