BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Erlotinib
Intervention description: 150 mg by mouth daily x 28 days
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; NSCLC; Erlotinib; Tarceva; OSI-774; Battle Program

Summary:

      The goal of this clinical research study is to learn if erlotinib hydrochloride (OSI-774,
      Tarceva®) can help to control NSCLC. The safety of this drug will also be studied, as well as
      the drug's effect on different cells in the body and the participants' overall response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or
             fine-needle aspiration.

          2. The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable
             NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen.
             (Patients who have failed adjuvant or locally advanced therapy within 6 months are
             also eligible to participate in study).

          3. The patient has uni-dimensionally measurable NSCLC.

          4. Karnofsky performance status >/= 60 or ECOG performance status 0-2

          5. The patient has biopsy accessible tumor.

          6. The patient has adequate hematologic function as defined by an absolute neutrophil
             count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, WBC >/= 3,000/ mm^3, and
             hemoglobin >/= 9 g/dL.

          7. The patient has adequate hepatic function as defined by a total bilirubin level </=
             1.5 X the upper limit of normal, and alkaline phosphatase, AST or ALT </= 2.5 X the
             upper limit of normal.

          8. The patient has adequate renal function as defined by a serum creatinine level </= 1.5
             mg/dL or a calculated creatinine clearance of >/= 60cc/minute.

          9. The patient has PT < 1.5 x upper limit of normal

         10. If patient has brain metastasis, they must have been stable (treated or asymptomatic)
             for at least 4 weeks after radiation, if treated with radiation, and not have used
             steroids for at least 1 week. Re-imaging performed after 2 weeks, upon completion of
             radiation therapy.

         11. The patient is >/= 18 years of age.

         12. The patient has signed informed consent.

         13. The patient is eligible if disease free from a previously treated malignancy, other
             than a previous NSCLC, for greater than two years. Patients with a history of prior
             basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt
             from exclusion.

         14. Women of childbearing potential must agree to use adequate contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry and for the duration
             of tudy participation. Childbearing potential will be defined as women who have had
             menses within the past 12 months,who have not had tubal ligation or bilateral
             oophorectomy.Should a woman become pregnant or suspect that she is pregnant while
             participating in this study,she should inform her treating physician immediately.The
             patient,if a man,agrees to use effective contraception or abstinence.

         15. Subject must be considered legally capable of providing his or her own consent for
             participation in this study.

        Exclusion Criteria:

          1. The patient has received prior investigational therapy, chemotherapy, surgery, or
             radiotherapy within 4 weeks of initiating study drug

          2. The patient has undergone prior thoracic or abdominal surgery within 28 days of study
             entry, excluding prior diagnostic biopsy.

          3. The patient has received radiation therapy to the measurable tumor within 6 months.
             Patients are allowed to have local irradiation for the management of tumor-related
             symptoms (bones, brain). However, if a patient has active new disease growing in the
             previously irradiated site, the patient will be eligible to participate in the study.

          4. The patient has a significant medical history or unstable medical condition (unstable
             systemic disease: congestive heart failure (New York Heart Association Functional
             Classification class II or worse), recent myocardial infarction within 3 months,
             unstable angina, active infection (i.e. currently treated with antibiotics,
             uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient
             must be able to undergo procedure for tissue acquisition.

          5. The patient has uncontrolled seizure disorder, active neurologic disease, or
             neuropathy >/= grade 2. Patients with meningeal or CNS involvement by tumor are
             eligible for the study if the above exclusion criteria are not met.

          6. The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.

          7. Any condition that is unstable or could jeopardize the safety of the patient and its
             compliance in the study, in the investigator's judgment.

          8. The patient is actively taking herbal remedies or over-the-counter biologics (e.g.,
             shark cartilage, high dose antioxidants).

          9. Patients will be allowed to have prior biologic (i.e. VEGF, EGFR, etc.) therapy.
             However, the patient will be excluded from a given study if he/she has received the
             same therapy as the clinical trial (i.e. If a patient has been previously treated with
             bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient has been
             previously treated with erlotinib, they are excluded from the clinical trials with
             erlotinib). In addition, if a patient has been previously treated with gefitinib
             (Iressa), they are excluded from the clinical trials with erlotinib.

         10. The patient has dysphagia. A patient who is unable to swallow intact capsules must be
             able to swallow capsules dissolved in water.

         11. The patient has active gastrointestinal disease or a disorder that alters
             gastrointestinal motility or absorption (i.e., lack of integrity of the
             gastrointestinal tract such as a significant surgical resection of the stomach or
             small bowel).