Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer; Brain Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms
Intervention: Tarceva (Erlotinib hydrochloride); Radiation Therapy
Intervention description: 150 mg by mouth every day beginning Day 1.; Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer; NSCLC; Brain Metastases; Brain Cancer; Lung Cancer; Tarceva; Erlotinib Hydrochloride; OSI-774; Radiation Therapy; Whole Brain Radiation Therapy; WBRT

Summary:

      The goal of this clinical research study is to learn whether Tarceva (erlotinib
      hydrochloride), when given in addition to whole brain radiation therapy, is better to treat
      brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological confirmation of non-small cell lung cancer

          2. Patients who have been treated in the past with stereotactic radiosurgery,
             stereotactic radiotherapy, GliaSite or surgical resection will be allowed to enroll in
             this study

          3. A diagnostic contrast-enhanced MRI or CT scan must be performed, demonstrating brain
             metastases

          4. Age 18-70

          5. Patients must have KPS >/= 70

          6. Patients cannot be treated on any other treatment related protocols within 30 days
             prior to study entry or during participation in the study

          7. No uncontrolled or symptomatic major medical illnesses or psychiatric impairments,
             such as Alzheimer's or schizophrenia

          8. Screening Clinical Laboratory Values: ANC >1500/ul, Platelets >80,000/ul, baseline AST
             and/or ALT within normal limits (within 30 days of starting protocol treatment)

          9. All women of childbearing potential (A woman of child-bearing potential is a sexually
             mature woman who has not undergone a hysterectomy or who has not been naturally
             postmenopausal for at least 24 consecutive months [i.e., who has had menses at any
             time in the preceding 24 consecutive months]) and male participants must practice
             effective contraception (abstinence, oral, injectable, or implantable hormonal
             contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
             spermicide; or vasectomized partner) throughout the study.

         10. Continued from #10: All women of child-bearing potential must have a negative serum
             pregnancy test and practice birth control while on study.

         11. Patients must provide verbal and written informed consent to participate in the study.

        Exclusion Criteria:

          1. Prior cranial radiation therapy, other than stereotactic radiosurgery, Stereotactic
             Radiotherapy or GliaSite.

          2. Patients with known Acquired Immune Deficiency (AIDS), as regimens with tyrosine
             kinase inhibitors may pose a safety risk related to excess toxicity or interference
             with anti-viral effectiveness

          3. Women who are pregnant or lactating, due to possible adverse effects on the developing
             fetus or infant due to study drug

          4. Patients with active connective tissue disorders, such as lupus or scleroderma