- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00324987
Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (S0502)
A Phase III Randomized Study of Imatinib, With or Without Bevacizumab (NSC-704865), in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors
Descripción general del estudio
Estado
Condiciones
Descripción detallada
PRIMARY OBJECTIVES:
I. To determine whether treatment with imatinib (imatinib mesylate) plus bevacizumab leads to improved progression free survival (PFS) versus treatment with imatinib alone in first-line treatment of incurable gastrointestinal stromal tumor (GIST).
SECONDARY OBJECTIVES:
I. To compare response probabilities (confirmed and unconfirmed complete response [CR] and partial response [PR] for subset of patients with measurable disease), overall survival, and central-review based progression-free survival (CRb-PFS) in patients treated with imatinib and bevacizumab versus those treated with imatinib alone.
II. To compare the frequency and severity of toxicities associated with imatinib plus bevacizumab versus imatinib alone.
TERTIARY OBJECTIVES:
I. To explore the association between soluble vascular endothelial growth factor (VEGF), VEGF-factor D (VEGF-D), VEGF receptor (VEGFR)-1, VEGFR-2, angiopoietin-2 (Ang-2), platelet-derived growth factor receptor (PDGFR)-AA and PDGFR-BB levels, positron emission tomography (PET) imaging and immunohistochemistry for cyclin-dependent kinase inhibitor 2A (p16), VEGF and VEGFR, with kinase mutation status and clinical outcomes.
II. To explore imatinib pharmacokinetics with single nucleotide polymorphisms involving the adenosine triphosphate (ATP)-binding cassette, sub-family G (WHITE), member 2 (ABCG2) and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) genes, as well as other genes that are reported to influence the absorption, distribution, metabolism and elimination of imatinib.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (CLOSED TO ACCRUAL 10/1/2009): Patients receive imatinib mesylate orally (PO) once daily (QD) on days 1-21 and bevacizumab intravenously (IV) over 30-90 minutes on day 1.
ARM II (CLOSED TO ACCRUAL 10/1/2009): Patients receive imatinib mesylate PO QD on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 6 months for 2 years, and then annually for 5 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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California
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Berkeley, California, Estados Unidos, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burlingame, California, Estados Unidos, 94010
- Mills - Peninsula Hospitals
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Greenbrae, California, Estados Unidos, 94904
- Marin General Hospital
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Los Angeles, California, Estados Unidos, 90033
- USC / Norris Comprehensive Cancer Center
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Novato, California, Estados Unidos, 94945
- Sutter Cancer Research Consortium
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San Francisco, California, Estados Unidos, 94118
- California Pacific Medical Center-Pacific Campus
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Vallejo, California, Estados Unidos, 94589
- Sutter Solano Medical Center/Cancer Center
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District of Columbia
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Washington, D.C., District of Columbia, Estados Unidos, 20007
- MedStar Georgetown University Hospital
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Georgia
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Columbus, Georgia, Estados Unidos, 31904
- John B Amos Cancer Center
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Savannah, Georgia, Estados Unidos, 31404
- Memorial University Medical Center
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Valdosta, Georgia, Estados Unidos, 31603
- South Georgia Medical Center
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Illinois
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Aurora, Illinois, Estados Unidos, 60504
- Rush - Copley Medical Center
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Estados Unidos, 60631
- Presence Resurrection Medical Center
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Decatur, Illinois, Estados Unidos, 62526
- Decatur Memorial Hospital
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Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology-Hematology Associates Limited
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La Grange, Illinois, Estados Unidos, 60525
- Adventist La Grange Memorial Hospital
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Naperville, Illinois, Estados Unidos, 60540
- Edward Hospital/Cancer Center
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Springfield, Illinois, Estados Unidos, 62781
- Memorial Medical Center
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center
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Urbana, Illinois, Estados Unidos, 61801
- Carle Clinic-Urbana Main
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Indiana
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Beech Grove, Indiana, Estados Unidos, 46107
- Franciscan St. Francis Health-Beech Grove
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Michigan City, Indiana, Estados Unidos, 46360
- Franciscan Saint Anthony Health-Michigan City
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Richmond, Indiana, Estados Unidos, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic PC-William R Bliss Cancer Center
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Clive, Iowa, Estados Unidos, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Davenport, Iowa, Estados Unidos, 52803
- Genesis Medical Center - East Campus
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Davenport, Iowa, Estados Unidos, 52804
- Genesis Medical Center - West Campus
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Des Moines, Iowa, Estados Unidos, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Estados Unidos, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Estados Unidos, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Estados Unidos, 50314
- Medical Oncology and Hematology Associates-Laurel
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Des Moines, Iowa, Estados Unidos, 50307
- Mercy Capitol
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Des Moines, Iowa, Estados Unidos, 50309
- Iowa Oncology Research Association CCOP
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Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Estados Unidos, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Estados Unidos, 51104
- Mercy Medical Center-Sioux City
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Kansas
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Chanute, Kansas, Estados Unidos, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Estados Unidos, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Estados Unidos, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Estados Unidos, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Estados Unidos, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Estados Unidos, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Estados Unidos, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Estados Unidos, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Estados Unidos, 67401
- Salina Regional Health Center
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Salina, Kansas, Estados Unidos, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Estados Unidos, 67208
- Associates In Womens Health
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Estados Unidos, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Estados Unidos, 67214
- Wichita CCOP
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Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Estados Unidos, 49221
- Bixby Medical Center
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Adrian, Michigan, Estados Unidos, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Estados Unidos, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Estados Unidos, 48106
- Michigan Cancer Research Consortium CCOP
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Dearborn, Michigan, Estados Unidos, 48124
- Oakwood Hospital and Medical Center
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Detroit, Michigan, Estados Unidos, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Estados Unidos, 48502
- Hurley Medical Center
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Flint, Michigan, Estados Unidos, 48532
- Genesys Regional Medical Center-West Flint Campus
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Jackson, Michigan, Estados Unidos, 49201
- Allegiance Health
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Lansing, Michigan, Estados Unidos, 48912
- Sparrow Hospital
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Livonia, Michigan, Estados Unidos, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Estados Unidos, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Estados Unidos, 48162
- Toledo Clinic Cancer Centers-Monroe
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Pontiac, Michigan, Estados Unidos, 48341
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Estados Unidos, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Estados Unidos, 48601
- Saint Mary's of Michigan
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Saint Joseph, Michigan, Estados Unidos, 49085
- Oncology Care Associates PLLC
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Southfield, Michigan, Estados Unidos, 48075
- Providence Hospital-Southfield Cancer Center
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Warren, Michigan, Estados Unidos, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- Essentia Health Cancer Center
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Duluth, Minnesota, Estados Unidos, 55805
- Essentia Health Saint Mary's Medical Center
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Duluth, Minnesota, Estados Unidos, 55805
- Miller-Dwan Hospital
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Hutchinson, Minnesota, Estados Unidos, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Estados Unidos, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Estados Unidos, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Estados Unidos, 55407
- Virginia Piper Cancer Institute
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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Saint Paul, Minnesota, Estados Unidos, 55102
- Saint Joseph's Hospital - Healtheast
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Shakopee, Minnesota, Estados Unidos, 55379
- Saint Francis Regional Medical Center
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Woodbury, Minnesota, Estados Unidos, 55125
- Woodwinds Health Campus
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Missouri
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Springfield, Missouri, Estados Unidos, 65804
- Cancer Research for the Ozarks NCORP
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Springfield, Missouri, Estados Unidos, 65804
- Mercy Hospital Springfield
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Montana
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Billings, Montana, Estados Unidos, 59101
- Saint Vincent Healthcare
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Billings, Montana, Estados Unidos, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Estados Unidos, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Estados Unidos, 59102
- Frontier Cancer Center and Blood Institute-Billings
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Billings, Montana, Estados Unidos, 59107
- Billings Clinic Cancer Center
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Bozeman, Montana, Estados Unidos, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Estados Unidos, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Estados Unidos, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Estados Unidos, 59405
- Great Falls Clinic
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Great Falls, Montana, Estados Unidos, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Estados Unidos, 59501
- Northern Montana Hospital
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Helena, Montana, Estados Unidos, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Estados Unidos, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Estados Unidos, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Estados Unidos, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Estados Unidos, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Estados Unidos, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Estados Unidos, 59801
- Community Medical Hospital
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Missoula, Montana, Estados Unidos, 59802
- Montana Cancer Specialists
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New Jersey
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Mount Holly, New Jersey, Estados Unidos, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
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Voorhees, New Jersey, Estados Unidos, 08043
- Virtua West Jersey Hospital Voorhees
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New York
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Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
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Glens Falls, New York, Estados Unidos, 12801
- Glens Falls Hospital
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Middletown, New York, Estados Unidos, 10940
- Orange Regional Medical Center
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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Rochester, New York, Estados Unidos, 14620
- Highland Hospital
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Rochester, New York, Estados Unidos, 14623
- Interlakes Foundation Inc-Rochester
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North Carolina
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Kinston, North Carolina, Estados Unidos, 28501
- Kinston Medical Specialists PA
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Sanford Bismarck Medical Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, Estados Unidos, 58501
- Saint Alexius Medical Center
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Ohio
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Bowling Green, Ohio, Estados Unidos, 43402
- Toledo Clinic Cancer Centers-Bowling Green
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Cincinnati, Ohio, Estados Unidos, 45267
- University of Cincinnati
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Clyde, Ohio, Estados Unidos, 43410
- North Coast Cancer Care-Clyde
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Dayton, Ohio, Estados Unidos, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Estados Unidos, 45409
- Miami Valley Hospital
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Dayton, Ohio, Estados Unidos, 45415
- Samaritan North Health Center
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Dayton, Ohio, Estados Unidos, 45405
- Grandview Hospital
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Dayton, Ohio, Estados Unidos, 45420
- Dayton CCOP
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Dayton, Ohio, Estados Unidos, 45428
- Veteran Affairs Medical Center
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Elyria, Ohio, Estados Unidos, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, Estados Unidos, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, Estados Unidos, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Estados Unidos, 45331
- Wayne Hospital
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Kettering, Ohio, Estados Unidos, 45429
- Kettering Medical Center
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Lima, Ohio, Estados Unidos, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Estados Unidos, 43537
- Toledo Clinic Cancer Centers-Maumee
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Maumee, Ohio, Estados Unidos, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
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Maumee, Ohio, Estados Unidos, 43537
- Saint Luke's Hospital
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Oregon, Ohio, Estados Unidos, 43616
- Saint Charles Hospital
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Oregon, Ohio, Estados Unidos, 43616
- Toledo Clinic Cancer Centers-Oregon
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Sandusky, Ohio, Estados Unidos, 44870
- North Coast Cancer Care
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Sylvania, Ohio, Estados Unidos, 43560
- Flower Hospital
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Tiffin, Ohio, Estados Unidos, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Estados Unidos, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, Estados Unidos, 43623
- Toledo Clinic Cancer Centers-Toledo
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Toledo, Ohio, Estados Unidos, 43614
- University of Toledo
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Toledo, Ohio, Estados Unidos, 43617
- Toledo Community Hospital Oncology Program CCOP
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Toledo, Ohio, Estados Unidos, 43606
- The Toledo Hospital/Toledo Children's Hospital
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Toledo, Ohio, Estados Unidos, 43623
- Mercy Saint Anne Hospital
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Troy, Ohio, Estados Unidos, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, Estados Unidos, 43567
- Fulton County Health Center
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Wilmington, Ohio, Estados Unidos, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Estados Unidos, 45385
- Greene Memorial Hospital
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Oregon
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Portland, Oregon, Estados Unidos, 97216
- Adventist Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Wilkes-Barre, Pennsylvania, Estados Unidos, 18765
- Geisinger South Wilkes-Barre
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
- Rapid City Regional Hospital
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- University Hospital
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Estados Unidos, 78209
- Audie L Murphy Veterans Affairs Hospital
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Virginia
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Fredericksburg, Virginia, Estados Unidos, 22401
- Fredericksburg Oncology Inc
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Washington
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Bellingham, Washington, Estados Unidos, 98225
- PeaceHealth Saint Joseph Medical Center
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Bremerton, Washington, Estados Unidos, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
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Kennewick, Washington, Estados Unidos, 99336
- Kadlec Clinic Hematology and Oncology
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Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Seattle, Washington, Estados Unidos, 98104
- Harborview Medical Center
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Seattle, Washington, Estados Unidos, 98104
- Minor and James Medical PLLC
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Seattle, Washington, Estados Unidos, 98112
- Group Health Cooperative-Seattle
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Seattle, Washington, Estados Unidos, 98122-4307
- Swedish Medical Center-First Hill
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Seattle, Washington, Estados Unidos, 98122
- The Polyclinic
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Seattle, Washington, Estados Unidos, 98112
- Group Health Cooperative of Puget Sound Oncology Consortium
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Spokane, Washington, Estados Unidos, 99202
- Cancer Care Northwest - Spokane South
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Wenatchee, Washington, Estados Unidos, 98801
- Wenatchee Valley Hospital and Clinics
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25304
- West Virginia University Charleston
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Wisconsin
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Chippewa Falls, Wisconsin, Estados Unidos, 54729
- Marshfield Clinic-Chippewa Center
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Eau Claire, Wisconsin, Estados Unidos, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
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Eau Claire, Wisconsin, Estados Unidos, 54701
- Sacred Heart Hospital
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Clinic
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Marshfield, Wisconsin, Estados Unidos, 54449
- Saint Joseph's Hospital
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Minocqua, Wisconsin, Estados Unidos, 54548
- Marshfield Clinic-Minocqua Center
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Rhinelander, Wisconsin, Estados Unidos, 54501
- Marshfield Clinic at James Beck Cancer Center
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Rice Lake, Wisconsin, Estados Unidos, 54868
- Marshfield Clinic-Rice Lake Center
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Stevens Point, Wisconsin, Estados Unidos, 54481
- Saint Michael's Hospital
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Wausau, Wisconsin, Estados Unidos, 54401
- Marshfield Clinic-Wausau Center
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Weston, Wisconsin, Estados Unidos, 54476
- Diagnostic and Treatment Center
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Weston, Wisconsin, Estados Unidos, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Estados Unidos, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Sheridan, Wyoming, Estados Unidos, 82801
- Welch Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- REGISTRATION # 1
- Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) that is distantly metastatic or unresectable; patients must be determined to be unresectable for cure
- Patient may have measurable and/or non-measurable disease; computed tomography (CT) or magnetic resonance imaging (MRI) used for measurable disease must have been completed within 28 days prior to registration; CT or MRI used for non-measurable disease must have been completed within 42 days prior to registration; PET scans are not sufficient for disease assessment; all disease must be assessed and documented on the Baseline Tumor Assessment Form
- CT/MRI scans must be performed and submitted for central review; archived tissue must be submitted as outlined
- Institutions must seek additional patient consent for PET scans as outlined; if patient consents to the submission of PET scans, the patient must also be registered to Registration #2
- Patient must not have known brain metastasis
- Patient must have a Zubrod performance status of 0 - 3
- Patient must have resolution of transient toxicities from any prior chemotherapy, radiation therapy or surgery to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
- Patient may have previously received traditional chemotherapeutic agents in any setting, provided at least 28 days have elapsed since completing chemotherapy and they have recovered to =< grade 1 from all drug-induced toxicities
Patient must not have received prior treatment with bevacizumab or other agents targeting VEGF, VEGFR, or PDGFR for advanced disease; those agents may have been used in the adjuvant setting if the patient did not recur for at least 12 months following the completion of treatment; patients may be receiving imatinib for advanced disease prior to registration provided they meet ALL of the following criteria:
- Patient must not have received more than 30 days of imatinib treatment prior to registration
- Patients have not been restaged; (baseline disease assessments prior to initiation of imatinib must fulfill requirements)
- Patients must have no clinical signs of progression
- Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment and there is evidence of progressive disease within the radiation field or disease outside the radiation field
- Patient must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, or anticipation of need for major surgical procedure during the course of the study; no fine needle aspirations or core biopsies are allowed within 7 days prior to registration; no procedure to place a port-a-cath is allowed within 7 days prior to registration
- Patient must have a total bilirubin =< 2.0 x institutional upper limit of normal (IULN), obtained within 28 days prior to registration
- Patients without liver involvement must have serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 2.5 x IULN, obtained within 28 days prior to registration; patients with liver involvement must have SGOT or SGPT =< 5 x IULN
- Patient must have adequate renal function as defined by a serum creatinine =< 1.5 x IULN obtained within 28 days prior to registration
- Patient must have urine protein/creatinine ratio (UPC) < 1; this result must be obtained within 28 days prior to registration
- Patient must have an absolute neutrophil count (ANC) >= 1,000/mcl obtained within 28 days prior to registration
- Patient must have a platelet count >= 100,000/mcl obtained within 28 days prior to registration
- Patient must have hemoglobin >= 9 gm/dl (this may be achieved by transfusion if needed) obtained within 28 days prior to registration
- Patient must have an international normalized ratio (INR) =< 1.5, obtained within 28 days prior to registration
- Patient must have a partial thromboplastin time (PTT) =< IULN, obtained within 28 days prior to registration
- Patient must not be taking therapeutic doses of Coumadin (warfarin) as anticoagulation at the time of registration; patients requiring therapeutic anticoagulation may use low-molecular weight heparin (e.g., Lovenox) or other agents, and mini-dose Coumadin (1 mg PO QD) as prophylaxis is allowed
- Patient must not have had a cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction or unstable angina within 6 months prior to registration; patient must not have serious cardiac arrhythmia requiring medication, New York Heart Association (NYHA) class II or greater congestive heart failure, or clinically significant peripheral vascular disease
- Patient must not have had an abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to registration
- Patient must not plan to use other investigational agents while on protocol treatment
- Patient must have no contraindication to oral medications (e.g., severe dysphagia); patients with gastrostomy (G)- or jejunostomy (J)- tubes are eligible
- Patient must not have blood pressure > 160/90; patients with a history of hypertension must be on a stable regimen of anti-hypertensive therapy
- Patient must not have a serious, non-healing wound, ulcer, or bone fracture
- Patient must not be pregnant or nursing; male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout protocol treatment and for up to 6 months following discontinuation of study drugs
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
- If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day; in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
- REGISTRATION #2 - PET SUBSTUDY:
- Patient must have been registered to the main study
- Patient must have consented to the submission of PET scans
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm I (CLOSED TO ACCRUAL 10/1/2009) (imatinib and bevacizumab)
Patients receive imatinib mesylate PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Estudios correlativos
Estudios correlativos
Dado IV
Otros nombres:
Orden de compra dada
Otros nombres:
|
Comparador activo: Arm II (CLOSED TO ACCRUAL 10/1/2009) (imatinib)
Patients receive imatinib mesylate PO QD on days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Estudios correlativos
Estudios correlativos
Orden de compra dada
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progression Free Survival
Periodo de tiempo: Up to 7 years
|
From date of registration (defined as date of randomization) to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.
Patients last known to be alive and progression free are censored at last date of contact.
Progression is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), provided at least one target lesion does NOT demonstrate uniform hypoattenuation over > 90% of maximal cross sectional area; unequivocal progression of non-measurable disease; appearance of new lesion/site that is not uniformly hypoattenuating; a hyperattenuating region within a previously cystic/uniformly hypoattenuating lesion will be considered progressive disease if hyperattenuating region is either >= 1 cm in longest diameter or round/oval and forms acute margins with border of target lesion; death due to disease.
|
Up to 7 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Response Rate
Periodo de tiempo: Up to 7 years
|
Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration.
Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration.
Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR.
Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
|
Up to 7 years
|
Overall Survival
Periodo de tiempo: up to 7 years
|
From date of registration (defined as date of randomization) to date of death due to any cause.
Patients last known to be alive are censored at last date of contact.
Note: median was not reached in the Imatinib arm due to limited follow-up data.
|
up to 7 years
|
Central-review Based Progression-free Survival (CRb-PFS)
Periodo de tiempo: up to 7 years
|
From date of registration (defined as date of randomization) to date of first documentation of one of the following events: death; first documentation of progression based on central review of the appropriate computed tomography (CT) or magnetic resonance imaging (MRI) scans; development of new lesions or disease not identified on CT or MRI; or symptomatic deterioration.
Patients not experiencing any of these events will be censored at last date of contact.
|
up to 7 years
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Periodo de tiempo: Up to 7 years
|
Only adverse events that are possibly, probably or definitely related to study drug are reported.
|
Up to 7 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charles Blanke, Southwest Oncology Group
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Del Tejido Conectivo
- Tumores del estroma gastrointestinal
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Factores inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Inhibidores de la proteína quinasa
- Anticuerpos
- Inmunoglobulinas
- Bevacizumab
- Anticuerpos Monoclonales
- Agentes antineoplásicos inmunológicos
- Mesilato de imatinib
- Inmunoglobulina G
- Factores de crecimiento endotelial
Otros números de identificación del estudio
- NCI-2009-00776 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- U10CA032102 (Subvención/contrato del NIH de EE. UU.)
- U10CA180888 (Subvención/contrato del NIH de EE. UU.)
- CDR0000482236
- S0502 (CTEP)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Tumor del estroma gastrointestinal
-
Hospital Universitario Virgen de la ArrixacaAún no reclutandoEnfermedades del HIGADO | Trasplante de hígado | Neoplasias Hepaticas | Tumores del estroma gastrointestinal | Metástasis | Metástasis hepáticas | Trasplante de hígado; Complicaciones | Cáncer de hígado | Trastorno de trasplante de hígado | Carcinoma de hígado | GIST maligno | ESENCIA | Metástasis | Cáncer de hígado... y otras condicionesEspaña
-
National Cancer Institute (NCI)TerminadoTumor carcinoide gastrointestinal metastásico | Tumor carcinoide gastrointestinal recidivante | Tumor carcinoide gastrointestinal regionalEstados Unidos
-
Seoul National University HospitalReclutamientoTumor submucoso del tracto gastrointestinalCorea, república de
-
National Cheng-Kung University HospitalNational Cheng Kung University; National Research Program for Biopharmaceuticals... y otros colaboradoresTerminadoTumor submucoso del tracto gastrointestinalTaiwán
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National Cancer Institute (NCI)Activo, no reclutandoTumor del estroma gastrointestinal metastásico | Sarcoma metastásico | Sarcoma localmente avanzado | Tumor del estroma gastrointestinal localmente avanzado | Tumor del estroma gastrointestinal gástrico y omental en estadio III AJCC v8 | Tumor del estroma gastrointestinal del intestino delgado... y otras condicionesEstados Unidos
-
Centre Leon BerardReclutamientoTumor del estroma gastrointestinal metastásico | Tumor del estroma gastrointestinal irresecable (GIST) | Tumor del estroma gastrointestinal localmente avanzado (GIST)Francia
-
Centre Leon BerardReclutamientoMutación C-KIT | Tumor metastásico del estroma gastrointestinal (GIST) | Tumor del estroma gastrointestinal avanzado (GIST)Francia
-
National Cancer Institute (NCI)TerminadoGastrinoma | Glucagonoma | Insulinoma | Tumor carcinoide gastrointestinal metastásico | Tumor de polipéptido pancreático | Tumor carcinoide gastrointestinal recidivante | Carcinoma de células de los islotes recidivante | Somatostatinoma | Tumor carcinoide gastrointestinal regional | Tumor carcinoide pulmonarEstados Unidos
-
University Hospital Plymouth NHS TrustTerminadoResección quirúrgica de un tumor maligno gastrointestinal superior | Suplementación nutricional a través de una yeyunostomía posterior al alta hospitalariaReino Unido
-
Ascentage Pharma Group Inc.HealthQuest Pharma Inc.ReclutamientoTumor Sólido, Adulto | Tumor del estroma gastrointestinal (GIST)Porcelana
Ensayos clínicos sobre Análisis de biomarcadores de laboratorio
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ORIOL BESTARDTerminadoTrasplante de riñón | Infección por CMVEspaña, Bélgica
-
Vanderbilt University Medical Center4DMedicalTerminado
-
Johns Hopkins UniversityReclutamiento
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Aún no reclutandoInfecciones por VIH | Hepatitis B
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University of MiamiActivo, no reclutando
-
Hvidovre University HospitalElsassFondenTerminadoAcidosis metabólica del recién nacidoDinamarca
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Rio de Janeiro State UniversityCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... y otros colaboradoresTerminadoEnfermedades cardiovasculares | Deficiencia de vitamina D | Condiciones relacionadas con la menopausiaBrasil