Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, squamous cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Squamous cell histology allowed No mixed histology with small cell component Stage IIIB (with pleural effusion) or stage IV disease Presence of peritoneal or pericardial effusion alone in the absence of cytologic evidence is not allowed Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan If the only site of measurable disease was previously irradiated, progressive disease must be evident Ineligible for bevacizumab therapy No symptomatic, untreated, or uncontrolled CNS metastases CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after completion of WBRT PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy ≥ 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 9 g/dL Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 3 times upper limit of normal (ULN) ALT and AST ≤ 3 times ULN (5 times ULN if liver involvement) Alkaline phosphatase ≤ 5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective nonhormonal contraception No proteinuria ≥ 1+ No uncontrolled blood pressure (BP), defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg in spite of adequate antihypertensive therapy No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection) No seizure disorder No significant traumatic injury within 4 weeks prior to study entry No second primary malignancy except any of the following: Carcinoma in situ of the cervix Nonmelanoma skin cancer Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence History of low-grade (Gleason score ≤ 6) localized prostate cancer even if diagnosed < 5 years prior to registration Treated stage I breast cancer ≤ 5 years prior to registration No uncontrolled intercurrent illness, including, but not limited to, any of the following: Ongoing or active infection Significant pulmonary symptoms at baseline due to disease Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situation that would limit compliance with study requirements Baseline hemoptysis Cavitating lesions No QTc prolongation > 500 msec or other significant ECG abnormality within the past 14 days No New York Heart Association class III or IV disease PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy for advanced lung cancer Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months allowed More than 12 months since prior immunotherapy and biologic therapy More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases) At least 2 weeks since prior WBRT No radiotherapy to ≥ 25% of bone marrow No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study entry (2 weeks for minor surgery) Insertion of a vascular access device not considered major or minor surgery No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent grapefruit or grapefruit juice during AZD2171 treatment No concurrent drugs or biologics with proarrhythmic potential Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of radiotherapy)
Sites / Locations
- Mayo Clinic Scottsdale
- Mayo Clinic - Jacksonville
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- McDonough District Hospital
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- South Bend Clinic
- 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
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Holland Community Hospital
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Hackley Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Munson Medical Center
- St. John Macomb Hospital
- Metro Health Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Immanuel St. Joseph's
- 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
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- HealthEast Cancer Care at St. Joseph's Hospital
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Regions Hospital Cancer Care Center
- Ridgeview Medical Center
- HealthEast Cancer Care at Woodwinds Health Campus
- Minnesota Oncology Hematology, PA - Woodbury
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- Roswell Park Cancer Institute
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Altru Cancer Center at Altru Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Geisinger Cancer Institute at Geisinger Health
- Geisinger Hazleton Cancer Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- Mercy Hospital at Wilkes-Barre
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Franciscan Skemp Healthcare - La Crosse Campus
- Bay Area Cancer Care Center at Bay Area Medical Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21. Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease, partial response, or complete response after 6 courses of therapy receive AZD2171 alone as above. Treatment with AZD2171 repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.