Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (S0502)
15 augusti 2017 uppdaterad av: National Cancer Institute (NCI)
A Phase III Randomized Study of Imatinib, With or Without Bevacizumab (NSC-704865), in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors
This randomized phase III trial studies imatinib mesylate and bevacizumab to see how well they work compared to imatinib mesylate alone in treating patients with gastrointestinal stromal tumor that has spread to other parts of the body or cannot be removed by surgery.
Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread.
It is not yet known whether imatinib mesylate and bevacizumab are more effective than imatinib mesylate alone in treating gastrointestinal stromal tumor.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Berkeley, California, Förenta staterna, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burlingame, California, Förenta staterna, 94010
- Mills - Peninsula Hospitals
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Greenbrae, California, Förenta staterna, 94904
- Marin General Hospital
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Los Angeles, California, Förenta staterna, 90033
- USC / Norris Comprehensive Cancer Center
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Novato, California, Förenta staterna, 94945
- Sutter Cancer Research Consortium
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San Francisco, California, Förenta staterna, 94118
- California Pacific Medical Center-Pacific Campus
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Vallejo, California, Förenta staterna, 94589
- Sutter Solano Medical Center/Cancer Center
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District of Columbia
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Washington, D.C., District of Columbia, Förenta staterna, 20007
- MedStar Georgetown University Hospital
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Georgia
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Columbus, Georgia, Förenta staterna, 31904
- John B Amos Cancer Center
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Savannah, Georgia, Förenta staterna, 31404
- Memorial University Medical Center
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Valdosta, Georgia, Förenta staterna, 31603
- South Georgia Medical Center
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Illinois
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Aurora, Illinois, Förenta staterna, 60504
- Rush - Copley Medical Center
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Förenta staterna, 60631
- Presence Resurrection Medical Center
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Joliet, Illinois, Förenta staterna, 60435
- Joliet Oncology-Hematology Associates Limited
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La Grange, Illinois, Förenta staterna, 60525
- Adventist La Grange Memorial Hospital
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Naperville, Illinois, Förenta staterna, 60540
- Edward Hospital/Cancer Center
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Springfield, Illinois, Förenta staterna, 62781
- Memorial Medical Center
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
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Urbana, Illinois, Förenta staterna, 61801
- Carle Clinic-Urbana Main
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- Franciscan St. Francis Health-Beech Grove
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Michigan City, Indiana, Förenta staterna, 46360
- Franciscan Saint Anthony Health-Michigan City
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Richmond, Indiana, Förenta staterna, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic PC-William R Bliss Cancer Center
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Clive, Iowa, Förenta staterna, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Davenport, Iowa, Förenta staterna, 52803
- Genesis Medical Center - East Campus
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Davenport, Iowa, Förenta staterna, 52804
- Genesis Medical Center - West Campus
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Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Förenta staterna, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates-Laurel
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Des Moines, Iowa, Förenta staterna, 50307
- Mercy Capitol
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Des Moines, Iowa, Förenta staterna, 50309
- Iowa Oncology Research Association CCOP
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Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Förenta staterna, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Förenta staterna, 51104
- Mercy Medical Center-Sioux City
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Förenta staterna, 67401
- Salina Regional Health Center
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Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Förenta staterna, 67208
- Associates In Womens Health
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Förenta staterna, 67214
- Wichita CCOP
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Förenta staterna, 49221
- Bixby Medical Center
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Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Förenta staterna, 48106
- Michigan Cancer Research Consortium CCOP
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Dearborn, Michigan, Förenta staterna, 48124
- Oakwood Hospital and Medical Center
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Detroit, Michigan, Förenta staterna, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Förenta staterna, 48502
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48532
- Genesys Regional Medical Center-West Flint Campus
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Jackson, Michigan, Förenta staterna, 49201
- Allegiance Health
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Lansing, Michigan, Förenta staterna, 48912
- Sparrow Hospital
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Livonia, Michigan, Förenta staterna, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Förenta staterna, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Förenta staterna, 48162
- Toledo Clinic Cancer Centers-Monroe
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Pontiac, Michigan, Förenta staterna, 48341
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Förenta staterna, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Förenta staterna, 48601
- Saint Mary's of Michigan
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Saint Joseph, Michigan, Förenta staterna, 49085
- Oncology Care Associates PLLC
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Southfield, Michigan, Förenta staterna, 48075
- Providence Hospital-Southfield Cancer Center
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Warren, Michigan, Förenta staterna, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Duluth, Minnesota, Förenta staterna, 55805
- Essentia Health Cancer Center
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Duluth, Minnesota, Förenta staterna, 55805
- Essentia Health Saint Mary's Medical Center
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Duluth, Minnesota, Förenta staterna, 55805
- Miller-Dwan Hospital
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Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Förenta staterna, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Förenta staterna, 55407
- Virginia Piper Cancer Institute
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Saint Paul, Minnesota, Förenta staterna, 55102
- Saint Joseph's Hospital - Healtheast
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Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
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Woodbury, Minnesota, Förenta staterna, 55125
- Woodwinds Health Campus
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Missouri
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Springfield, Missouri, Förenta staterna, 65804
- Cancer Research for the Ozarks NCORP
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Springfield, Missouri, Förenta staterna, 65804
- Mercy Hospital Springfield
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Montana
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Billings, Montana, Förenta staterna, 59101
- Saint Vincent Healthcare
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Billings, Montana, Förenta staterna, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Förenta staterna, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Förenta staterna, 59102
- Frontier Cancer Center and Blood Institute-Billings
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Billings, Montana, Förenta staterna, 59107
- Billings Clinic Cancer Center
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Förenta staterna, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic
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Great Falls, Montana, Förenta staterna, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Förenta staterna, 59501
- Northern Montana Hospital
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Helena, Montana, Förenta staterna, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Förenta staterna, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Förenta staterna, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Förenta staterna, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Förenta staterna, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Förenta staterna, 59801
- Community Medical Hospital
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Missoula, Montana, Förenta staterna, 59802
- Montana Cancer Specialists
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New Jersey
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Mount Holly, New Jersey, Förenta staterna, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
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Voorhees, New Jersey, Förenta staterna, 08043
- Virtua West Jersey Hospital Voorhees
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New York
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Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
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Glens Falls, New York, Förenta staterna, 12801
- Glens Falls Hospital
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Middletown, New York, Förenta staterna, 10940
- Orange Regional Medical Center
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Rochester, New York, Förenta staterna, 14642
- University of Rochester
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Rochester, New York, Förenta staterna, 14620
- Highland Hospital
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Rochester, New York, Förenta staterna, 14623
- Interlakes Foundation Inc-Rochester
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North Carolina
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Kinston, North Carolina, Förenta staterna, 28501
- Kinston Medical Specialists PA
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501
- Sanford Bismarck Medical Center
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Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, Förenta staterna, 58501
- Saint Alexius Medical Center
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Ohio
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Bowling Green, Ohio, Förenta staterna, 43402
- Toledo Clinic Cancer Centers-Bowling Green
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Cincinnati, Ohio, Förenta staterna, 45267
- University of Cincinnati
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Clyde, Ohio, Förenta staterna, 43410
- North Coast Cancer Care-Clyde
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Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
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Dayton, Ohio, Förenta staterna, 45415
- Samaritan North Health Center
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Dayton, Ohio, Förenta staterna, 45405
- Grandview Hospital
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Dayton, Ohio, Förenta staterna, 45420
- Dayton CCOP
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Dayton, Ohio, Förenta staterna, 45428
- Veteran Affairs Medical Center
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Elyria, Ohio, Förenta staterna, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
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Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
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Lima, Ohio, Förenta staterna, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Förenta staterna, 43537
- Toledo Clinic Cancer Centers-Maumee
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Maumee, Ohio, Förenta staterna, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
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Maumee, Ohio, Förenta staterna, 43537
- Saint Luke's Hospital
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Oregon, Ohio, Förenta staterna, 43616
- Saint Charles Hospital
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Oregon, Ohio, Förenta staterna, 43616
- Toledo Clinic Cancer Centers-Oregon
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Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care
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Sylvania, Ohio, Förenta staterna, 43560
- Flower Hospital
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Tiffin, Ohio, Förenta staterna, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Förenta staterna, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic Cancer Centers-Toledo
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Toledo, Ohio, Förenta staterna, 43614
- University of Toledo
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Toledo, Ohio, Förenta staterna, 43617
- Toledo Community Hospital Oncology Program CCOP
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Toledo, Ohio, Förenta staterna, 43606
- The Toledo Hospital/Toledo Children's Hospital
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Toledo, Ohio, Förenta staterna, 43623
- Mercy Saint Anne Hospital
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Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, Förenta staterna, 43567
- Fulton County Health Center
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Wilmington, Ohio, Förenta staterna, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Förenta staterna, 45385
- Greene Memorial Hospital
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Oregon
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Portland, Oregon, Förenta staterna, 97216
- Adventist Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
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Wilkes-Barre, Pennsylvania, Förenta staterna, 18765
- Geisinger South Wilkes-Barre
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
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Texas
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San Antonio, Texas, Förenta staterna, 78229
- University Hospital
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San Antonio, Texas, Förenta staterna, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Förenta staterna, 78209
- Audie L Murphy Veterans Affairs Hospital
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Virginia
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Fredericksburg, Virginia, Förenta staterna, 22401
- Fredericksburg Oncology Inc
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Washington
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Bellingham, Washington, Förenta staterna, 98225
- PeaceHealth Saint Joseph Medical Center
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Bremerton, Washington, Förenta staterna, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
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Kennewick, Washington, Förenta staterna, 99336
- Kadlec Clinic Hematology and Oncology
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Seattle, Washington, Förenta staterna, 98195
- University of Washington Medical Center
-
Seattle, Washington, Förenta staterna, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Seattle, Washington, Förenta staterna, 98104
- Harborview Medical Center
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Seattle, Washington, Förenta staterna, 98104
- Minor and James Medical PLLC
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Seattle, Washington, Förenta staterna, 98112
- Group Health Cooperative-Seattle
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Seattle, Washington, Förenta staterna, 98122-4307
- Swedish Medical Center-First Hill
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Seattle, Washington, Förenta staterna, 98122
- The Polyclinic
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Seattle, Washington, Förenta staterna, 98112
- Group Health Cooperative of Puget Sound Oncology Consortium
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Spokane, Washington, Förenta staterna, 99202
- Cancer Care Northwest - Spokane South
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Wenatchee, Washington, Förenta staterna, 98801
- Wenatchee Valley Hospital and Clinics
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West Virginia
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Charleston, West Virginia, Förenta staterna, 25304
- West Virginia University Charleston
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Wisconsin
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Chippewa Falls, Wisconsin, Förenta staterna, 54729
- Marshfield Clinic-Chippewa Center
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Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
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Eau Claire, Wisconsin, Förenta staterna, 54701
- Sacred Heart Hospital
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Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Clinic
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Marshfield, Wisconsin, Förenta staterna, 54449
- Saint Joseph's Hospital
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Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Clinic-Minocqua Center
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Rhinelander, Wisconsin, Förenta staterna, 54501
- Marshfield Clinic at James Beck Cancer Center
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Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Clinic-Rice Lake Center
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Stevens Point, Wisconsin, Förenta staterna, 54481
- Saint Michael's Hospital
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Wausau, Wisconsin, Förenta staterna, 54401
- Marshfield Clinic-Wausau Center
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Weston, Wisconsin, Förenta staterna, 54476
- Diagnostic and Treatment Center
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Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center
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-
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Alberta
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Calgary, Alberta, Kanada, T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Korrelativa studier
Korrelativa studier
Givet IV
Andra namn:
Givet PO
Andra namn:
|
|
Aktiv komparator: 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.
|
Korrelativa studier
Korrelativa studier
Givet PO
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression Free Survival
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Response Rate
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: Up to 7 years
|
Only adverse events that are possibly, probably or definitely related to study drug are reported.
|
Up to 7 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Charles Blanke, Southwest Oncology Group
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2008
Primärt slutförande (Faktisk)
1 juli 2015
Avslutad studie (Faktisk)
1 juli 2015
Studieregistreringsdatum
Först inskickad
10 maj 2006
Först inskickad som uppfyllde QC-kriterierna
10 maj 2006
Första postat (Uppskatta)
11 maj 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer, bindväv och mjukvävnad
- Neoplasmer efter histologisk typ
- Neoplasmer
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Neoplasmer, bindväv
- Gastrointestinala stromala tumörer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Immunologiska faktorer
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Antikroppar
- Immunoglobuliner
- Bevacizumab
- Antikroppar, monoklonala
- Antineoplastiska medel, immunologiska
- Imatinib Mesylate
- Immunoglobulin G
- Endoteltillväxtfaktorer
Andra studie-ID-nummer
- NCI-2009-00776 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
- U10CA180888 (U.S.S. NIH-anslag/kontrakt)
- CDR0000482236
- S0502 (CTEP)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .