Pemetrexed Disodium, Carboplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
Eligibility Criteria
Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma including bronchoalveolar cell, and large cell anaplastic carcinoma (including giant and clear cell carcinomas) Eligible Disease Stages: Inoperable IIIA and Selected IIIB - Patients entered must be considered unresectable or inoperable. Patients do not need to have a mediastinoscopy. A size of 2 cm or greater by CT is a sufficient criterion for the diagnosis of mediastinal lymph node (N2 or N3) involvement by malignancy. If the largest mediastinal lymph node is less than 2 cm in diameter, a biopsy confirmation of mediastinal nodal involvement is required. The following patients are eligible: Patients must be M0 Patients with any T with N2 or N3 are eligible Patients with T3, N1-N3 disease are eligible if deemed unresectable Patients with T4, any N are eligible provided the T4 status is not determined because of malignant effusion Patients with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed in the radiation field in accordance with the homogeneity criteria Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can 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 will be eligible. Patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible. The following patients are NOT eligible: Patients with T3, N0 disease Patients with M1 disease Patients with atelectasis of the entire lung Patients with direct invasion of vertebral body Patients with scalene, supraclavicular, or contralateral hilar node involvement Patients with exudative, bloody, or cytologically malignant effusions Patients must have Measurable Disease: Lesions 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 CT scan. Lesions that are not considered measurable include bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, abdominal masses that are not confirmed and followed by imaging techniques, cystic lesions and tumor lesions situated in a previously irradiated area. Prior Therapy: ≥ 2 weeks since formal exploratory thoracotomy. No prior chemotherapy for NSCLC, chest radiation therapy or therapy that specifically and directly targets the EGFR pathway ECOG performance status 0-1 Positron Emission Tomography (PET) using 18 fluorodeoxyglucose (FDG) must be negative for distant metastasis. PET imaging is mandatory. Weight loss of ≤ 10% in the past 3 months No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. Non-pregnant and non-nursing because of significant risk to the fetus/infant Age ≥ 18 years No patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness. No HIV-positive patients receiving combination anti-retroviral therapy because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy No known history of hypersensitivity to carboplatin, pemetrexed or a monoclonal antibody Required Initial Laboratory Values: Granulocytes ≥ 1,500/mcl Platelets ≥ 100,000/mcl Calculated Creatinine Clearance ≥ 45 ml/min Bilirubin < 1.5 x ULN AST/ALT < 3 x ULN Alkaline Phosphatase < 3 x ULN
Sites / Locations
- Arroyo Grande Community Hospital
- Eden Medical Center
- Saint Rose Hospital
- Rebecca and John Moores UCSD Cancer Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- CCOP - Bay Area Tumor Institute
- Valley Care Medical Center
- Doctors Medical Center - San Pablo Campus
- Bendheim Cancer Center at Greenwich Hospital
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Sibley Memorial Hospital
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- La Grange Memorial Hospital
- Fort Wayne Medical Oncology and Hematology
- Hematology Oncology Associates of the Quad Cities
- Iowa Blood and Cancer Care
- St. Luke's Hospital
- Mercy Regional Cancer Center at Mercy Medical Center
- Holden Comprehensive Cancer Center at University of Iowa
- Greenebaum Cancer Center at University of Maryland Medical Center
- Upper Chesapeake Medical Center
- Union Hospital Cancer Program at Union Hospital
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
- Saint Luke's Hospital
- Missouri Cancer Associates
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
- St. Anthony's Cancer Center
- Missouri Baptist Cancer Center
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
- Callahan Cancer Center at Great Plains Regional Medical Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Elliot Regional Cancer Center at Elliot Hospital
- St. Joseph's Hospital and Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- CCOP - Hematology-Oncology Associates of Central New York
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Mount Sinai Medical Center
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Mission Hospitals - Memorial Campus
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Duke Comprehensive Cancer Center
- Wayne Memorial Hospital, Incorporated
- Pardee Memorial Hospital
- Kinston Medical Specialists
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Oklahoma University Cancer Institute
- Cancer Care Associates - Mercy Campus
- Rhode Island Hospital Comprehensive Cancer Center
- Miriam Hospital
- Roper St. Francis Cancer Center at Roper Hospital
- McLeod Regional Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- Danville Regional Medical Center
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- Virginia Commonwealth University Massey Cancer Center
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Std Tx + Pemetrexed
Std Tx + Pemetrexed and Cetuximab
Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.