Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Not Recruiting

Trial ID: NCT00979212


RATIONALE: Drugs used in chemotherapy (CT), such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy (RT) uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without panitumumab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see how well they work when given with or without panitumumab in treating patients with stage IIIA non-small cell lung cancer.

Official Title

Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab (IND #110152) Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer

Stanford Investigator(s)


Professor of Radiation Oncology (Radiation Therapy)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Quynh-Thu Le, MD
Quynh-Thu Le, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)

Joseph Shrager
Joseph Shrager

Professor of Cardiothoracic Surgery



   - Histologically confirmed* non-small cell lung cancer (NSCLC), including any of the
   following histologies:

      - Adenocarcinoma

      - Adenosquamous

      - Large cell carcinoma

      - Squamous cell carcinoma

      - Non-lobar and non-diffuse bronchoalveolar cell carcinoma

      - NSCLC not otherwise specified NOTE: *Documentation of NSCLC may originate from
      the mediastinal node biopsy or aspiration

   - Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive
   ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar
   nodes (N1)

      - N2 nodes must be separate from primary tumor by either CT scan or surgical

      - Maximum nodal diameter of involved N2 nodes cannot exceed 3.0 cm

      - N2 status must be pathologically confirmed to be positive by one of the following

         - Mediastinoscopy

         - Mediastinotomy (Chamberlain procedure)

         - Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)

         - Endobronchial ultrasound biopsy using endoscopic ultrasound guidance

         - Thoracotomy

         - Video-assisted thoracoscopy

         - Transbronchial needle biopsy by Wang technique (TBNA)

         - Fine-needle aspiration under CT guidance NOTE: *PET positivity in the
         ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal

      - Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied
      unless all of the following are true:

         - Tumor is left sided

         - Paralyzed left true vocal cord documented by bronchoscopy or indirect

         - Nodes visible in the anterior/posterior (level 5) region on CT scan

         - Distinct primary tumor separate from nodes visible on CT scan

         - Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of
         non-small cell histology from the primary tumor

      - If lymph nodes in the contralateral mediastinum and neck are visible on contrast
      CT scan of the chest and are > 1.0 cm in short axis or if contralateral
      involvement is suggested by PET scan, then the nodes must be confirmed to be

   - Measurable disease as determined by contrast-enhanced CT scan

      - Primary lung tumor distinct from mediastinal lymph nodes

   - If a pleural effusion is present, the following criteria must be met to exclude
   malignant involvement (incurable M1a disease):

      - When pleural fluid is visible on both the CT scan and on a chest x-ray, a
      pleuracentesis is required to confirm that the pleural fluid is cytologically

      - Exudative pleural effusions are excluded, regardless of cytology;

      - Effusions that are minimal (i.e. not visible under ultrasound guidance) that are
      too small to safely tap are eligible.

   - No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless
   proven to be benign by fine-needle aspiration or biopsy

   - No distant metastases


   - Zubrod performance status 0-1

   - Absolute neutrophil count (ANC) ≥ 1,500/mm³

   - Platelet count ≥ 100,000/mm³

   - Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

   - Creatinine clearance ≥ 60 mL/min

   - Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

   - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

   - Alkaline phosphatase ≤ 2.5 times ULN

   - Serum albumin > 3.0 g/dL

   - Serum magnesium normal (supplementation allowed)

   - Not pregnant

   - Negative pregnancy test

   - Fertile patients must use effective contraception during and for 6 months after
   completion of treatment

   - Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1
   ≥ 0.8 L

   - Diffusion capacity ≥ 50% predicted

   - No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer
   or carcinoma in situ of the breast, oral cavity, or cervix

   - No severe, active co-morbidity, including any of the following:

      - Current uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable
      angina, myocardial infarction within the past 6 months, uncontrolled congestive
      heart failure, or cardiomyopathy with decreased ejection fraction (<50%)

      - Acute bacterial or fungal infection requiring IV antibiotics

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or that would preclude study therapy within the past 4

      - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

      - AIDS or known HIV positivity

   - No unintentional weight loss ≥ 5% of body weight within the past 6 months

   - No prior severe infusion reaction to a monoclonal antibody

   - No pre-existing peripheral neuropathy ≥ grade 2


   - No prior systemic chemotherapy or biological therapy (including erlotinib
   hydrochloride or similar agents) for the study cancer

      - Prior chemotherapy for a different cancer allowed

   - No prior radiotherapy to the region of the study cancer that would result in overlap
   of radiotherapy fields

   - No prior therapy that specifically and directly targets the EGFR pathway


drug: carboplatin

drug: paclitaxel

drug: panitumumab

procedure: surgery

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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