TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer; Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Carboplatin; Paclitaxel; Radiation Therapy
Intervention description: 150 mg by mouth daily for 7 Weeks; 2 AUC by vein weekly for 7 Weeks; 45 mg/m^2 by vein weekly for 7 Weeks; 63 GY/35 fractions for 7 weeks (+/- 5 days)
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; Squamous Cell Carcinoma; Adenocarcinoma; Bronchoalveolar Cell Carcinoma; Large Cell Anaplastic Carcinoma; Giant Cell Carcinoma; Clear Cell Carcinoma; Erlotinib; Erlotinib Hydrocholoride; OSI-774; Tarceva; Carboplatin; Paraplatin; Paclitaxel; Taxol; NSCLC

Summary:

      The goal of this clinical research study is to find out if erlotinib given with chemotherapy
      and radiation therapy can help to control NSCLC. The safety of this combination treatment
      will also be studied.

      Researchers will also test the tissue from your earlier biopsy to measure the levels of
      epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any
      link between various forms of EGFR and your response to treatment with erlotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically documented NSCLC, including squamous cell carcinoma,
             adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma
             (including giant and clear cell carcinomas) and poorly differentiated (not otherwise
             specified, NOS) non-small cell lung cancer; totally resected tumors are excluded. ·

          2. Patients must be M0;

          3. Patients with Tl or T2 disease with N2 or T3N1-2 disease (Stage IIIA) are eligible if
             they are deemed inoperable. Patients with T4 with any N or any T with N2 or N3 disease
             are eligible if unresectable. Radiographic evidence of mediastinal lymph nodes > 2.0
             cm in the largest diameter is sufficient to stage N2 or N3 disease. If the largest
             mediastinal node is < 2.0 cm in diameter and this is the basis for stage III disease,
             then at least one of the nodes must be proven positive cytologically or
             histologically;

          4. Measurable disease is required

          5. Patients with tumors adjacent to a vertebral body are eligible as long as all gross
             disease can be encompassed in the radiation boost field. The boost volume must be
             limited to < 50% of the ipsilateral lung volume.

          6. Patients must be greater than or equal to 18 years of age;

          7. Patients with Zubrod performance status 0-1

          8. Adequate hematologic function defined as: ANC greater than or equal 1,500/mm^3,
             platelets greater than or equal 100,000/mm^3, and hemoglobin greater than or equal 9
             g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin
             less than or equal to 1.5 mg/dl, SGOT or SGPT less than or equal to 3 x ULN, adequate
             renal function defined as a serum creatinine level less than or equal to 2.0 mg/dl,
             alkaline phosphatase less than or equal to 2.5 x ULN, glucose less than or equal to 2
             x ULN;

          9. FEV1 with greater than or equal to 1000 cc;

         10. Patients with weight loss less than or equal to than </= 10% over the past 3 months;

         11. Patients with a pleural effusion that is a transudate, cytologically negative and
             nonbloody are eligible if the radiation oncologists feel the tumor can still be
             encompassed within a reasonable field of radiotherapy. If a pleural effusion can be
             seen on the chest CT but not on CXR and is too small to tap, the patient is eligible.

         12. If patients had exploratory thoracotomy, they must have recovered from the procedure.
             Exploratory Thoracotomy and beginning of treatment should be within one month.

         13. 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 (oral, injectable, or implantable hormonal contraceptive;
             tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or
             vasectomized partner) throughout the study and for four weeks after completion of
             treatment.

         14. For women of childbearing potential, a urine or blood pregnancy test must be performed
             within 48 hours prior to the start of protocol treatment;

         15. Medical Oncology and Radiation Oncology consults and approval.

         16. Patients must sign a study-specific consent form prior to study entry.

        Exclusion Criteria:

          1. Prior systemic chemotherapy and/or thoracic radiotherapy for any reason and/or
             surgical resection of present cancer;

          2. Exudative, bloody, or cytologically malignant effusion or effusion that are exudative
             and/or bloody and are suggestive or malignant involvement.

          3. Prior therapy with any other drug that targets the EGFR pathway,

          4. Active pulmonary infection not responsive to conventional antibiotics;

          5. History of interstitial lung disease;

          6. History of severe COPD requiring greater than or equal to 3 hospitalizations over the
             past year;

          7. Significant history of cardiac disease, i.e., uncontrolled hypertension, unstable
             angina, uncompensated congestive heart failure, myocardial infarction within the past
             year, or cardiac ventricular arrhythmias requiring medication; patients with left
             ventricular ejection fraction (LVEF) below the institutional range of normal (50-70%)
             on a baseline multiple gated acquisition (MUGA) scan or echocardiogram.

          8. Patients with > grade 1 neuropathy;

          9. Evidence of malignancy in the past 3 years except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, or other in situ cancers;

         10. Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to
             the participant, embryo, fetus, or nursing infant; women with a positive pregnancy
             test on enrollment or prior to study drug administration;

         11. Women of childbearing potential and male participants who are unwilling or unable to
             use an acceptable method of contraception (oral, injectable, or implantable hormonal
             contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
             spermicide; or vasectomized partner) throughout the study and for four weeks after
             completion of treatment or those who are using a prohibited contraceptive method
             (methods with unknown efficacy).

         12. Patients who currently are participating in other clinical trials and/or who have
             participated in other clinical trials in the previous 30 days. Clinical trials
             involving administration of investigational agents or interfering with the safe
             conduct of this trial. All clinical trials would exclude observational trials which
             would not interfere with the endpoints of our study.