- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00326599
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
A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving gemcitabine and carboplatin together with AZD2171 may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and carboplatin together with AZD2171 works compared to giving gemcitabine and carboplatin without AZD2171 as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
Primary
- Assess the objective tumor response rate in patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride, carboplatin, and AZD2171 as first-line therapy.
Secondary
- Compare the proportion of patients who are progression-free at 6 months after treatment with gemcitabine hydrochloride and carboplatin with vs without AZD2171.
- Compare the duration of response for responding patients treated with these regimens.
- Compare the time-to-progression and time-to-treatment failure.
- Compare the 1-year overall survival.
- Compare the clinical toxicities.
- Assess the safety and tolerability of these regimens in these patients.
Tertiary
- Collect blood and tumor specimens for future evaluation of pharmacogenetic and proteomic markers of tumor response and toxicity to therapy with these agents.
- Bank paraffin-embedded tissue blocks/slides and blood samples for future histochemistry evaluation and DNA extraction.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: 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.
- Arm II: 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.
Patients undergo blood collection periodically during study for pharmacologic correlative studies.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
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Arizona
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Scottsdale, Arizona, Vereinigte Staaten, 85259-5499
- Mayo Clinic Scottsdale
-
-
Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224
- Mayo Clinic - Jacksonville
-
-
Illinois
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Aurora, Illinois, Vereinigte Staaten, 60504
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Vereinigte Staaten, 61701
- St. Joseph Medical Center
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Canton, Illinois, Vereinigte Staaten, 61520
- Graham Hospital
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Carthage, Illinois, Vereinigte Staaten, 62321
- Memorial Hospital
-
Eureka, Illinois, Vereinigte Staaten, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Vereinigte Staaten, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Vereinigte Staaten, 61401
- Galesburg Clinic, PC
-
Havana, Illinois, Vereinigte Staaten, 62644
- Mason District Hospital
-
Hopedale, Illinois, Vereinigte Staaten, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Vereinigte Staaten, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Macomb, Illinois, Vereinigte Staaten, 61455
- Mcdonough District Hospital
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Moline, Illinois, Vereinigte Staaten, 61265
-
Moline, Illinois, Vereinigte Staaten, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Normal, Illinois, Vereinigte Staaten, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Vereinigte Staaten, 61761
- Community Cancer Center
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Ottawa, Illinois, Vereinigte Staaten, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Vereinigte Staaten, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Vereinigte Staaten, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Vereinigte Staaten, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Vereinigte Staaten, 61614
- Proctor Hospital
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Peoria, Illinois, Vereinigte Staaten, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Vereinigte Staaten, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Vereinigte Staaten, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Vereinigte Staaten, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Vereinigte Staaten, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Vereinigte Staaten, 61362
- St. Margaret's Hospital
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Urbana, Illinois, Vereinigte Staaten, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Vereinigte Staaten, 61801
- CCOP - Carle Cancer Center
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Indiana
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Elkhart, Indiana, Vereinigte Staaten, 46515
- Elkhart General Hospital
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Kokomo, Indiana, Vereinigte Staaten, 46904
- Howard Community Hospital
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La Porte, Indiana, Vereinigte Staaten, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, Vereinigte Staaten, 46360
- Saint Anthony Memorial Health Centers
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South Bend, Indiana, Vereinigte Staaten, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Vereinigte Staaten, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Vereinigte Staaten, 46617
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Vereinigte Staaten, 46617
- South Bend Clinic
-
-
Iowa
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Bettendorf, Iowa, Vereinigte Staaten, 52722
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Cedar Rapids, Iowa, Vereinigte Staaten, 52403
- Cedar Rapids Oncology Associates
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Des Moines, Iowa, Vereinigte Staaten, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Vereinigte Staaten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Vereinigte Staaten, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Vereinigte Staaten, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Vereinigte Staaten, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Vereinigte Staaten, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Vereinigte Staaten, 50307
- Mercy Capitol Hospital
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Mason City, Iowa, Vereinigte Staaten, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Sioux City, Iowa, Vereinigte Staaten, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Vereinigte Staaten, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Vereinigte Staaten, 51104
- Mercy Medical Center - Sioux City
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Vereinigte Staaten, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Vereinigte Staaten, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Vereinigte Staaten, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Vereinigte Staaten, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Vereinigte Staaten, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Vereinigte Staaten, 48503
- Hurley Medical Center
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Flint, Michigan, Vereinigte Staaten, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Butterworth Hospital at Spectrum Health
-
Grand Rapids, Michigan, Vereinigte Staaten, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Vereinigte Staaten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Holland, Michigan, Vereinigte Staaten, 49423
- Holland Community Hospital
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Iron Mountain, Michigan, Vereinigte Staaten, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Vereinigte Staaten, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Vereinigte Staaten, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Vereinigte Staaten, 48154
- St. Mary Mercy Hospital
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Muskegon, Michigan, Vereinigte Staaten, 49442
- Hackley Hospital
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Pontiac, Michigan, Vereinigte Staaten, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Vereinigte Staaten, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Vereinigte Staaten, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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St. Joseph, Michigan, Vereinigte Staaten, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Vereinigte Staaten, 49684
- Munson Medical Center
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Warren, Michigan, Vereinigte Staaten, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, Vereinigte Staaten, 49519
- Metro Health Hospital
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Minnesota
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Bemidji, Minnesota, Vereinigte Staaten, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Vereinigte Staaten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Vereinigte Staaten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Vereinigte Staaten, 55805
- CCOP - Duluth
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Duluth, Minnesota, Vereinigte Staaten, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Vereinigte Staaten, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Vereinigte Staaten, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Vereinigte Staaten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Vereinigte Staaten, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, Vereinigte Staaten, 55355
- Meeker County Memorial Hospital
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Mankato, Minnesota, Vereinigte Staaten, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, Vereinigte Staaten, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Vereinigte Staaten, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Vereinigte Staaten, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Vereinigte Staaten, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Vereinigte Staaten, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Vereinigte Staaten, 55102
- United Hospital
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Saint Paul, Minnesota, Vereinigte Staaten, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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Shakopee, Minnesota, Vereinigte Staaten, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Vereinigte Staaten, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Vereinigte Staaten, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Vereinigte Staaten, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Woodbury, Minnesota, Vereinigte Staaten, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
-
-
Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Vereinigte Staaten, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
-
-
Montana
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Billings, Montana, Vereinigte Staaten, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Vereinigte Staaten, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, Vereinigte Staaten, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Vereinigte Staaten, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Vereinigte Staaten, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, Vereinigte Staaten, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Vereinigte Staaten, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Vereinigte Staaten, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Vereinigte Staaten, 59405
-
Havre, Montana, Vereinigte Staaten, 59501
- Northern Montana Hospital
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Helena, Montana, Vereinigte Staaten, 59601
- St. Peter's Hospital
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Kalispell, Montana, Vereinigte Staaten, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Vereinigte Staaten, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Vereinigte Staaten, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Vereinigte Staaten, 59801
- Community Medical Center
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Missoula, Montana, Vereinigte Staaten, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, Vereinigte Staaten, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Vereinigte Staaten, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Vereinigte Staaten, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Vereinigte Staaten, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Vereinigte Staaten, 68131-2197
- Creighton University Medical Center
-
-
New York
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Buffalo, New York, Vereinigte Staaten, 14263-0001
- Roswell Park Cancer Institute
-
-
North Dakota
-
Bismarck, North Dakota, Vereinigte Staaten, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Vereinigte Staaten, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Vereinigte Staaten, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Vereinigte Staaten, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Vereinigte Staaten, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Vereinigte Staaten, 58122
- MeritCare Broadway
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Grand Forks, North Dakota, Vereinigte Staaten, 58201
- Altru Cancer Center at Altru Hospital
-
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Oklahoma
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Tulsa, Oklahoma, Vereinigte Staaten, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
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Pennsylvania
-
Allentown, Pennsylvania, Vereinigte Staaten, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Danville, Pennsylvania, Vereinigte Staaten, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Vereinigte Staaten, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Vereinigte Staaten, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Vereinigte Staaten, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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Wilkes-Barre, Pennsylvania, Vereinigte Staaten, 18765
- Mercy Hospital at Wilkes-Barre
-
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South Dakota
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Rapid City, South Dakota, Vereinigte Staaten, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Vereinigte Staaten, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Vereinigte Staaten, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Vereinigte Staaten, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
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Wisconsin
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Green Bay, Wisconsin, Vereinigte Staaten, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Vereinigte Staaten, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Vereinigte Staaten, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Vereinigte Staaten, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
La Crosse, Wisconsin, Vereinigte Staaten, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
-
Marinette, Wisconsin, Vereinigte Staaten, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Oconto Falls, Wisconsin, Vereinigte Staaten, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, Vereinigte Staaten, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
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Wyoming
-
Sheridan, Wyoming, Vereinigte Staaten, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Arm I
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.
|
Gegeben IV
Gegeben IV
Mündlich gegeben
|
Aktiver Komparator: Arm II
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.
|
Gegeben IV
Gegeben IV
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)
Zeitfenster: Up to 5 years
|
A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
|
Up to 5 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)
Zeitfenster: 6 months
|
Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
6 months
|
Progression-free Survival (Phase II Patients Only)
Zeitfenster: Up to 5 years
|
Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first.
Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.
|
Up to 5 years
|
Time to Treatment Failure (Phase II Patients Only)
Zeitfenster: Up to 15 months
|
Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.
|
Up to 15 months
|
Overall Survival at 1 Year After Randomization (Phase II Patients Only)
Zeitfenster: 1 year
|
Overall survival was defined as the time from study enrollment to the time of death from any cause.
A patient is classified as a success if alive at 1 year.
|
1 year
|
Overall Survival (Phase II Patients Only)
Zeitfenster: Up to 5 years
|
Overall survival was defined as the time from study enrollment to the time of death from any cause.
Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.
|
Up to 5 years
|
Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)
Zeitfenster: Cycle 1 (up to 3 weeks)
|
DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities.
|
Cycle 1 (up to 3 weeks)
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- van Cruijsen H, Voest EE, Punt CJ, Hoekman K, Witteveen PO, Meijerink MR, Puchalski TA, Robertson J, Saunders O, Jurgensmeier JM, van Herpen CM, Giaccone G. Phase I evaluation of cediranib, a selective VEGFR signalling inhibitor, in combination with gefitinib in patients with advanced tumours. Eur J Cancer. 2010 Mar;46(5):901-11. doi: 10.1016/j.ejca.2009.12.023. Epub 2010 Jan 12.
- Dy GK, Mandrekar SJ, Nelson GD, Meyers JP, Adjei AA, Ross HJ, Ansari RH, Lyss AP, Stella PJ, Schild SE, Molina JR, Adjei AA. A randomized phase II study of gemcitabine and carboplatin with or without cediranib as first-line therapy in advanced non-small-cell lung cancer: North Central Cancer Treatment Group Study N0528. J Thorac Oncol. 2013 Jan;8(1):79-88. doi: 10.1097/JTO.0b013e318274a85d.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Karzinom, nicht-kleinzellige Lunge
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Proteinkinase-Inhibitoren
- Gemcitabin
- Carboplatin
- Cediranib
Andere Studien-ID-Nummern
- NCCTG-N0528
- NCI-2012-02694 (Registrierungskennung: CTRP (Clinical Trials Reporting System))
- CDR0000468945 (Registrierungskennung: PDQ (Physician Data Query))
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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