Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00126581

Run by

National Cancer Institute (NCI)

People needed

188

Starts

2005-08-15

Expected to finish

2017-11-28

Last updated by the study team

2019-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Saint Rose Hospital — Hayward, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• El Camino Hospital — Mountain View, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Hematology and Oncology Associates-Oakland — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• University of California San Diego — San Diego, California, United States
• Kaiser Permanente-San Diego Mission — San Diego, California, United States
• Veterans Administration-San Diego Medical Center — San Diego, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• Doctors Medical Center- JC Robinson Regional Cancer Center — San Pablo, California, United States
• Middlesex Hospital — Middletown, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States

Full record on ClinicalTrials.gov

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