Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (S0502)
15. august 2017 oppdatert 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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California
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Berkeley, California, Forente stater, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burlingame, California, Forente stater, 94010
- Mills - Peninsula Hospitals
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Greenbrae, California, Forente stater, 94904
- Marin General Hospital
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Los Angeles, California, Forente stater, 90033
- USC / Norris Comprehensive Cancer Center
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Novato, California, Forente stater, 94945
- Sutter Cancer Research Consortium
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San Francisco, California, Forente stater, 94118
- California Pacific Medical Center-Pacific Campus
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Vallejo, California, Forente stater, 94589
- Sutter Solano Medical Center/Cancer Center
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District of Columbia
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Washington, D.C., District of Columbia, Forente stater, 20007
- MedStar Georgetown University Hospital
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Georgia
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Columbus, Georgia, Forente stater, 31904
- John B Amos Cancer Center
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Savannah, Georgia, Forente stater, 31404
- Memorial University Medical Center
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Valdosta, Georgia, Forente stater, 31603
- South Georgia Medical Center
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Illinois
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Aurora, Illinois, Forente stater, 60504
- Rush - Copley Medical Center
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Chicago, Illinois, Forente stater, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Forente stater, 60631
- Presence Resurrection Medical Center
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Decatur, Illinois, Forente stater, 62526
- Decatur Memorial Hospital
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Joliet, Illinois, Forente stater, 60435
- Joliet Oncology-Hematology Associates Limited
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La Grange, Illinois, Forente stater, 60525
- Adventist La Grange Memorial Hospital
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Naperville, Illinois, Forente stater, 60540
- Edward Hospital/Cancer Center
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Springfield, Illinois, Forente stater, 62781
- Memorial Medical Center
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Urbana, Illinois, Forente stater, 61801
- Carle Cancer Center
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Urbana, Illinois, Forente stater, 61801
- Carle Clinic-Urbana Main
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Indiana
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Beech Grove, Indiana, Forente stater, 46107
- Franciscan St. Francis Health-Beech Grove
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Michigan City, Indiana, Forente stater, 46360
- Franciscan Saint Anthony Health-Michigan City
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Richmond, Indiana, Forente stater, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Forente stater, 50010
- McFarland Clinic PC-William R Bliss Cancer Center
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Clive, Iowa, Forente stater, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Davenport, Iowa, Forente stater, 52803
- Genesis Medical Center - East Campus
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Davenport, Iowa, Forente stater, 52804
- Genesis Medical Center - West Campus
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Des Moines, Iowa, Forente stater, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Forente stater, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forente stater, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Forente stater, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Forente stater, 50314
- Medical Oncology and Hematology Associates-Laurel
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Des Moines, Iowa, Forente stater, 50307
- Mercy Capitol
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Des Moines, Iowa, Forente stater, 50309
- Iowa Oncology Research Association CCOP
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Sioux City, Iowa, Forente stater, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Forente stater, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Forente stater, 51104
- Mercy Medical Center-Sioux City
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Kansas
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Chanute, Kansas, Forente stater, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Forente stater, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Forente stater, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Forente stater, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Forente stater, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Forente stater, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Forente stater, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Forente stater, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Forente stater, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Forente stater, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Forente stater, 67401
- Salina Regional Health Center
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Salina, Kansas, Forente stater, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Forente stater, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Forente stater, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Forente stater, 67208
- Associates In Womens Health
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Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Forente stater, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Forente stater, 67214
- Wichita CCOP
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Winfield, Kansas, Forente stater, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Forente stater, 49221
- Bixby Medical Center
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Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Forente stater, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Forente stater, 48106
- Michigan Cancer Research Consortium CCOP
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Dearborn, Michigan, Forente stater, 48124
- Oakwood Hospital and Medical Center
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Detroit, Michigan, Forente stater, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Forente stater, 48502
- Hurley Medical Center
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Flint, Michigan, Forente stater, 48532
- Genesys Regional Medical Center-West Flint Campus
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Jackson, Michigan, Forente stater, 49201
- Allegiance Health
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Lansing, Michigan, Forente stater, 48912
- Sparrow Hospital
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Livonia, Michigan, Forente stater, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Forente stater, 48162
- Toledo Clinic Cancer Centers-Monroe
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Pontiac, Michigan, Forente stater, 48341
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Forente stater, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Forente stater, 48601
- Saint Mary's of Michigan
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Saint Joseph, Michigan, Forente stater, 49085
- Oncology Care Associates PLLC
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Southfield, Michigan, Forente stater, 48075
- Providence Hospital-Southfield Cancer Center
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Warren, Michigan, Forente stater, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Duluth, Minnesota, Forente stater, 55805
- Essentia Health Cancer Center
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Duluth, Minnesota, Forente stater, 55805
- Essentia Health Saint Mary's Medical Center
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Duluth, Minnesota, Forente stater, 55805
- Miller-Dwan Hospital
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Hutchinson, Minnesota, Forente stater, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Forente stater, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Forente stater, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Forente stater, 55407
- Virginia Piper Cancer Institute
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Saint Paul, Minnesota, Forente stater, 55101
- Regions Hospital
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Saint Paul, Minnesota, Forente stater, 55102
- Saint Joseph's Hospital - Healtheast
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Shakopee, Minnesota, Forente stater, 55379
- Saint Francis Regional Medical Center
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Woodbury, Minnesota, Forente stater, 55125
- Woodwinds Health Campus
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Missouri
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Springfield, Missouri, Forente stater, 65804
- Cancer Research for the Ozarks NCORP
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Springfield, Missouri, Forente stater, 65804
- Mercy Hospital Springfield
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Montana
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Billings, Montana, Forente stater, 59101
- Saint Vincent Healthcare
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Billings, Montana, Forente stater, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Forente stater, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Forente stater, 59102
- Frontier Cancer Center and Blood Institute-Billings
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Billings, Montana, Forente stater, 59107
- Billings Clinic Cancer Center
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Bozeman, Montana, Forente stater, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Forente stater, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Forente stater, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Forente stater, 59405
- Great Falls Clinic
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Great Falls, Montana, Forente stater, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Forente stater, 59501
- Northern Montana Hospital
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Helena, Montana, Forente stater, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Forente stater, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Forente stater, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Forente stater, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Forente stater, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Forente stater, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Forente stater, 59801
- Community Medical Hospital
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Missoula, Montana, Forente stater, 59802
- Montana Cancer Specialists
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New Jersey
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Mount Holly, New Jersey, Forente stater, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
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Voorhees, New Jersey, Forente stater, 08043
- Virtua West Jersey Hospital Voorhees
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New York
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Buffalo, New York, Forente stater, 14263
- Roswell Park Cancer Institute
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Glens Falls, New York, Forente stater, 12801
- Glens Falls Hospital
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Middletown, New York, Forente stater, 10940
- Orange Regional Medical Center
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Rochester, New York, Forente stater, 14642
- University of Rochester
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Rochester, New York, Forente stater, 14620
- Highland Hospital
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Rochester, New York, Forente stater, 14623
- Interlakes Foundation Inc-Rochester
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North Carolina
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Kinston, North Carolina, Forente stater, 28501
- Kinston Medical Specialists PA
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North Dakota
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Bismarck, North Dakota, Forente stater, 58501
- Sanford Bismarck Medical Center
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Bismarck, North Dakota, Forente stater, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, Forente stater, 58501
- Saint Alexius Medical Center
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Ohio
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Bowling Green, Ohio, Forente stater, 43402
- Toledo Clinic Cancer Centers-Bowling Green
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Cincinnati, Ohio, Forente stater, 45267
- University of Cincinnati
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Clyde, Ohio, Forente stater, 43410
- North Coast Cancer Care-Clyde
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Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Forente stater, 45409
- Miami Valley Hospital
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Dayton, Ohio, Forente stater, 45415
- Samaritan North Health Center
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Dayton, Ohio, Forente stater, 45405
- Grandview Hospital
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Dayton, Ohio, Forente stater, 45420
- Dayton CCOP
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Dayton, Ohio, Forente stater, 45428
- Veteran Affairs Medical Center
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Elyria, Ohio, Forente stater, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, Forente stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Forente stater, 45331
- Wayne Hospital
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Kettering, Ohio, Forente stater, 45429
- Kettering Medical Center
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Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Forente stater, 43537
- Toledo Clinic Cancer Centers-Maumee
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Maumee, Ohio, Forente stater, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
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Maumee, Ohio, Forente stater, 43537
- Saint Luke's Hospital
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Oregon, Ohio, Forente stater, 43616
- Saint Charles Hospital
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Oregon, Ohio, Forente stater, 43616
- Toledo Clinic Cancer Centers-Oregon
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Sandusky, Ohio, Forente stater, 44870
- North Coast Cancer Care
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Sylvania, Ohio, Forente stater, 43560
- Flower Hospital
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Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Forente stater, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, Forente stater, 43623
- Toledo Clinic Cancer Centers-Toledo
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Toledo, Ohio, Forente stater, 43614
- University of Toledo
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Toledo, Ohio, Forente stater, 43617
- Toledo Community Hospital Oncology Program CCOP
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Toledo, Ohio, Forente stater, 43606
- The Toledo Hospital/Toledo Children's Hospital
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Toledo, Ohio, Forente stater, 43623
- Mercy Saint Anne Hospital
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Troy, Ohio, Forente stater, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
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Wilmington, Ohio, Forente stater, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Forente stater, 45385
- Greene Memorial Hospital
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Oregon
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Portland, Oregon, Forente stater, 97216
- Adventist Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Fox Chase Cancer Center
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Wilkes-Barre, Pennsylvania, Forente stater, 18765
- Geisinger South Wilkes-Barre
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Rapid City Regional Hospital
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Texas
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San Antonio, Texas, Forente stater, 78229
- University Hospital
-
San Antonio, Texas, Forente stater, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Forente stater, 78209
- Audie L Murphy Veterans Affairs Hospital
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Virginia
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Fredericksburg, Virginia, Forente stater, 22401
- Fredericksburg Oncology Inc
-
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Washington
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Bellingham, Washington, Forente stater, 98225
- PeaceHealth Saint Joseph Medical Center
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Bremerton, Washington, Forente stater, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
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Kennewick, Washington, Forente stater, 99336
- Kadlec Clinic Hematology and Oncology
-
Seattle, Washington, Forente stater, 98195
- University of Washington Medical Center
-
Seattle, Washington, Forente stater, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
Seattle, Washington, Forente stater, 98104
- Harborview Medical Center
-
Seattle, Washington, Forente stater, 98104
- Minor and James Medical PLLC
-
Seattle, Washington, Forente stater, 98112
- Group Health Cooperative-Seattle
-
Seattle, Washington, Forente stater, 98122-4307
- Swedish Medical Center-First Hill
-
Seattle, Washington, Forente stater, 98122
- The Polyclinic
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Seattle, Washington, Forente stater, 98112
- Group Health Cooperative of Puget Sound Oncology Consortium
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Spokane, Washington, Forente stater, 99202
- Cancer Care Northwest - Spokane South
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Wenatchee, Washington, Forente stater, 98801
- Wenatchee Valley Hospital and Clinics
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West Virginia
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Charleston, West Virginia, Forente stater, 25304
- West Virginia University Charleston
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Wisconsin
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Chippewa Falls, Wisconsin, Forente stater, 54729
- Marshfield Clinic-Chippewa Center
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Eau Claire, Wisconsin, Forente stater, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
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Eau Claire, Wisconsin, Forente stater, 54701
- Sacred Heart Hospital
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Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Clinic
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Marshfield, Wisconsin, Forente stater, 54449
- Saint Joseph's Hospital
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Minocqua, Wisconsin, Forente stater, 54548
- Marshfield Clinic-Minocqua Center
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Rhinelander, Wisconsin, Forente stater, 54501
- Marshfield Clinic at James Beck Cancer Center
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Rice Lake, Wisconsin, Forente stater, 54868
- Marshfield Clinic-Rice Lake Center
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Stevens Point, Wisconsin, Forente stater, 54481
- Saint Michael's Hospital
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Wausau, Wisconsin, Forente stater, 54401
- Marshfield Clinic-Wausau Center
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Weston, Wisconsin, Forente stater, 54476
- Diagnostic and Treatment Center
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Weston, Wisconsin, Forente stater, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Forente stater, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Korrelative studier
Korrelative studier
Gitt IV
Andre navn:
Gitt PO
Andre navn:
|
|
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.
|
Korrelative studier
Korrelative studier
Gitt PO
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Response Rate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Up to 7 years
|
Only adverse events that are possibly, probably or definitely related to study drug are reported.
|
Up to 7 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Charles Blanke, Southwest Oncology Group
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2008
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først innsendt
10. mai 2006
Først innsendt som oppfylte QC-kriteriene
10. mai 2006
Først lagt ut (Anslag)
11. mai 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer, bindevev og mykt vev
- Neoplasmer etter histologisk type
- Neoplasmer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer, bindevev
- Gastrointestinale stromale svulster
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Immunologiske faktorer
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Antistoffer
- Immunoglobuliner
- Bevacizumab
- Antistoffer, monoklonale
- Antineoplastiske midler, immunologiske
- Imatinibmesylat
- Immunoglobulin G
- Endotelvekstfaktorer
Andre studie-ID-numre
- NCI-2009-00776 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- U10CA032102 (U.S. NIH-stipend/kontrakt)
- U10CA180888 (U.S. NIH-stipend/kontrakt)
- CDR0000482236
- S0502 (CTEP)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .