Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Tarceva (Erlotinib)
Intervention description: Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Carcinoma,non-small cell lung; preoperative; Tarceva; Response rate

Summary:

      The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking
      tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the
      tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib)
      . This type of CT scan will measure the tumor by volume and by standard measurement (length
      and width). Both methods will be compared to find out whether standard measurement or
      measurement by tumor volume is more accurate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical
             resection

          -  Ambulatory and capable of all self-care but may be unable to carry out any work
             activities.

          -  Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell
             medical center for purposes of volumetric measurements.

          -  Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.

          -  18 years and older.

          -  Women of child-bearing potential must be taking adequate contraceptive precautions
             prior to study entry and for the duration of study participation. A negative serum or
             urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and
             premenopausal women of child bearing potential will follow an approved, medically
             accepted birth control regimen or agree to abstain from heterosexual intercourse while
             taking study drug and for 30 days following the last dose of study drug.

        Exclusion Criteria:

          -  Cannot be on any other anti-cancer treatment during this study.

          -  Prior treatment with any EGFR inhibitor.

          -  Patients who had prior treatment with chemotherapy or radiation for this disease.

          -  Other active cancers.

          -  Tumors with a mixed histology of small cell and non-small cell carcinoma as well as
             patients with pulmonary carcinoid tumors.

          -  Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel
             disease.

          -  Hypersensitivity to compounds similar in chemical composition to Tarceva®.

          -  Active infection or serious underlying medical conditions which would impair protocol
             treatment.