Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
Condition: Lung Adenocarcinoma; Lung Adenosquamous Carcinoma; Malignant Pericardial Effusion; Malignant Pleural Effusion; Minimally Invasive Lung Adenocarcinoma; Stage IIIB Lung Non-Small Cell Cancer AJCC v7; Stage IV Lung Non-Small Cell Cancer AJCC v7
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung; Pleural Effusion, Malignant; Carcinoma, Adenosquamous; Adenocarcinoma, Bronchiolo-Alveolar; Pleural Effusion; Pericardial Effusion
Intervention: Carboplatin; Erlotinib; Erlotinib Hydrochloride; Paclitaxel
Intervention description: Given IV; Given PO; Given PO; Given IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: A Phase II Randomized Study of OSI-774

Summary:

      This randomized phase II trial studies how well erlotinib hydrochloride with or without
      carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung
      cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and
      paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib
      hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving
      either drug alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic documentation of primary lung adenocarcinoma including any variant thereof
             such as pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma;
             patients with non-small cell lung cancer (NSCLC) not otherwise specified (NOS) are not
             eligible

               -  Pathology block or unstained slides from initial or subsequent diagnosis must be
                  available for sequencing of EGFR, K-ras, Erb-2 and B-raf; patients need to have
                  had at least a core biopsy; patients whose diagnosis was made through a fine
                  needle aspirate will not have sufficient material for mutational analysis and are
                  not eligible

          -  Select stage IIIB with cytologically documented malignant pleural or pericardial
             effusion OR stage IV disease

          -  Patients must be chemotherapy naïve; they may not have received neo-adjuvant or
             adjuvant chemotherapy

          -  No prior exposure to OSI-774 (erlotinib) or other treatments targeting the human
             epidermal growth factor receptor (HER) family axis (e.g., trastuzumab, gefitinib,
             cetuximab, lapatinib, etc.)

          -  No uncontrolled central nervous system metastases (i.e., any known central nervous
             system [CNS] lesion which is radiographically unstable, symptomatic and/or requiring
             corticosteroids); patients must be >= 3 weeks beyond completing cranial irradiation
             and off corticosteroid therapy

          -  >= 3 weeks since prior radiation therapy

          -  >= 3 weeks since prior major surgery

          -  No treatment with an investigational agent currently or within the last 28 days

          -  Non-smoker or former light smoker; non-smoker is defined as a person who smoked =< 100
             cigarettes in their lifetime while a former light smoker is a patient who smoked
             between > 100 cigarettes AND =< 10 pack years AND quit >= 1 year ago; this must be
             documented on the On-study Form (C-1405)

          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1

          -  Non-pregnant and non-nursing

          -  No dysphagia or active gastrointestinal disease or disorder that alters
             gastrointestinal motility or absorption; no lack of integrity of the gastrointestinal
             tract (e.g., a significant surgical resection of the stomach or small bowel); patients
             unable to swallow intact tablets must be able to swallow tablets dissolved in water

          -  Measurable disease is defined as at least one lesion that can be accurately measured
             in at least one dimension (longest diameter to be recorded) as >= 20 mm with
             conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan;
             lesions that are considered non-measurable include the following:

               -  Bone lesions

               -  Leptomeningeal disease

               -  Ascites

               -  Pleural/pericardial effusion

               -  Lymphangitis cutis/pulmonis

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

          -  Granulocyte >= 1,500/mcl

          -  Platelet count >= 100,000/mcl

          -  Hemoglobin >= 9.0 g/dL

          -  Total bilirubin =< upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
             2.5 x ULN

          -  Creatinine =< 1.5 mg/dl