Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring bronchioalveolar carcinoma (BAC), adenocarcinoma with BAC features, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, cetuximab
Eligibility Criteria
INCLUSION CRITERIA: Histologically or cytologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features meeting 1 of the following stage criteria: Stage IIIB disease (with pleural or pericardial effusion) Stage IV disease Recurrent disease Measurable disease Tumor tissue available from biopsy Age of 18 and over ECOG performance status of 0-2 Life expectancy greater than 3 months White blood cell (WBC) ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin normal Aspartate aminotransferase (AST) and/or alanine aminotranferease (ALT) ≤ 2.5 times upper limit of normal Creatinine normal OR Creatinine clearance ≥ 60 mL/min No more than 1 prior chemotherapy regimen for advanced BAC More than 3 years since prior chemotherapy for other malignancies At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for this malignancy and recovered HIV-positive patients are eligible provided the following criteria are met: CD4 count ≥ 100/mm^3 Undetectable viral load within the past 3 months Receiving a stable antiretroviral regimen for ≥ 4 weeks before study entry Fertile patients must use effective contraception At least 2 weeks since prior radiotherapy and recovered EXCLUSION CRITERIA: Untreated brain metastases Patients with stable brain metastases ≥ 4 weeks after external beam radiotherapy to the brain are eligible Acute hepatitis Symptomatic congestive heart failure Uncontrolled hypertension Unstable angina pectoris Cardiac arrhythmia Pregnant or nursing Prior allergic reaction to chimerized or murine monoclonal antibody therapy Documented presence of human anti-mouse antibodies Ongoing or active infection Psychiatric illness or social situation that would preclude study compliance Other uncontrolled illness Prior cetuximab Concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Other prior known epidermal growth factor receptor inhibitors (e.g., gefitinib or erlotinib) Other concurrent investigational agents Other concurrent anticancer therapy
Sites / Locations
- Aurora Presbyterian Hospital
- Penrose Cancer Center at Penrose Hospital
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program
- Swedish Medical Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
- Baptist Cancer Institute - Jacksonville
- Rush-Copley Cancer Care Center
- Decatur Memorial Hospital Cancer Care Institute
- Joliet Oncology-Hematology Associates, Limited - West
- Swedish-American Regional Cancer Center
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, PC
- Cedar Rapids Oncology Associates
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Morton Hospital & Medical Center
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- St. John Macomb Hospital
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- HealthEast Cancer Care at St. Joseph's Hospital
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- HealthEast Cancer Care at Woodwinds Health Campus
- Minnesota Oncology Hematology, PA - Woodbury
- Veterans Affairs Medical Center - East Orange
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Booker Cancer Center at Riverview Medical Center
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Summa Center for Cancer Care at Akron City Hospital
- Wood County Oncology Center
- Aultman Cancer Center at Aultman Hospital
- Hematology Oncology Center
- St. Rita's Medical Center
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Fulton County Health Center
- St. Luke's Cancer Network at St. Luke's Hospital
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lewistown Hospital
- Cancer Center of Paoli Memorial Hospital
- Abramson Cancer Center of the University of Pennsylvania
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Albert Einstein Cancer Center
- UPMC Cancer Centers
- St. Joseph Medical Center
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Hematology and Oncology Associates of Northeastern Pennsylvania
- Geisinger Medical Group - Scenery Park
- Mount Nittany Medical Center
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- CCOP - Scott and White Hospital
- Fredericksburg Oncology, Incorporated
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Marshfield Clinic - Lakeland Center
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Saint Michael's Hospital Cancer Center
- Marshfield Clinic - Wausau Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Experimental
Cetuximab
Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.