Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (S0502)
15 augustus 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
12
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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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, Verenigde Staten, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burlingame, California, Verenigde Staten, 94010
- Mills - Peninsula Hospitals
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Greenbrae, California, Verenigde Staten, 94904
- Marin General Hospital
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Los Angeles, California, Verenigde Staten, 90033
- USC / Norris Comprehensive Cancer Center
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Novato, California, Verenigde Staten, 94945
- Sutter Cancer Research Consortium
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San Francisco, California, Verenigde Staten, 94118
- California Pacific Medical Center-Pacific Campus
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Vallejo, California, Verenigde Staten, 94589
- Sutter Solano Medical Center/Cancer Center
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District of Columbia
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Washington, D.C., District of Columbia, Verenigde Staten, 20007
- MedStar Georgetown University Hospital
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Georgia
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Columbus, Georgia, Verenigde Staten, 31904
- John B Amos Cancer Center
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Savannah, Georgia, Verenigde Staten, 31404
- Memorial University Medical Center
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Valdosta, Georgia, Verenigde Staten, 31603
- South Georgia Medical Center
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Illinois
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Aurora, Illinois, Verenigde Staten, 60504
- Rush - Copley Medical Center
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Chicago, Illinois, Verenigde Staten, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Verenigde Staten, 60631
- Presence Resurrection Medical Center
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Decatur, Illinois, Verenigde Staten, 62526
- Decatur Memorial Hospital
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Joliet, Illinois, Verenigde Staten, 60435
- Joliet Oncology-Hematology Associates Limited
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La Grange, Illinois, Verenigde Staten, 60525
- Adventist La Grange Memorial Hospital
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Naperville, Illinois, Verenigde Staten, 60540
- Edward Hospital/Cancer Center
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Springfield, Illinois, Verenigde Staten, 62781
- Memorial Medical Center
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Urbana, Illinois, Verenigde Staten, 61801
- Carle Cancer Center
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Urbana, Illinois, Verenigde Staten, 61801
- Carle Clinic-Urbana Main
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Indiana
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Beech Grove, Indiana, Verenigde Staten, 46107
- Franciscan St. Francis Health-Beech Grove
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Michigan City, Indiana, Verenigde Staten, 46360
- Franciscan Saint Anthony Health-Michigan City
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Richmond, Indiana, Verenigde Staten, 47374
- Reid Hospital and Health Care Services
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
- McFarland Clinic PC-William R Bliss Cancer Center
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Clive, Iowa, Verenigde Staten, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Davenport, Iowa, Verenigde Staten, 52803
- Genesis Medical Center - East Campus
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Davenport, Iowa, Verenigde Staten, 52804
- Genesis Medical Center - West Campus
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Des Moines, Iowa, Verenigde Staten, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, Verenigde Staten, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Verenigde Staten, 50314
- Medical Oncology and Hematology Associates-Laurel
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Des Moines, Iowa, Verenigde Staten, 50307
- Mercy Capitol
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Des Moines, Iowa, Verenigde Staten, 50309
- Iowa Oncology Research Association CCOP
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Sioux City, Iowa, Verenigde Staten, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Verenigde Staten, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, Verenigde Staten, 51104
- Mercy Medical Center-Sioux City
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Kansas
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Chanute, Kansas, Verenigde Staten, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Verenigde Staten, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Verenigde Staten, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Verenigde Staten, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Verenigde Staten, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Verenigde Staten, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, Verenigde Staten, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Verenigde Staten, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, Verenigde Staten, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, Verenigde Staten, 67401
- Salina Regional Health Center
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Salina, Kansas, Verenigde Staten, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Verenigde Staten, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Verenigde Staten, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, Verenigde Staten, 67208
- Associates In Womens Health
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Wichita, Kansas, Verenigde Staten, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, Verenigde Staten, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, Verenigde Staten, 67214
- Wichita CCOP
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Winfield, Kansas, Verenigde Staten, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Verenigde Staten, 49221
- Bixby Medical Center
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Adrian, Michigan, Verenigde Staten, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, Verenigde Staten, 48106
- Michigan Cancer Research Consortium CCOP
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Dearborn, Michigan, Verenigde Staten, 48124
- Oakwood Hospital and Medical Center
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Detroit, Michigan, Verenigde Staten, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, Verenigde Staten, 48502
- Hurley Medical Center
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Flint, Michigan, Verenigde Staten, 48532
- Genesys Regional Medical Center-West Flint Campus
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Jackson, Michigan, Verenigde Staten, 49201
- Allegiance Health
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Lansing, Michigan, Verenigde Staten, 48912
- Sparrow Hospital
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Livonia, Michigan, Verenigde Staten, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, Verenigde Staten, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, Verenigde Staten, 48162
- Toledo Clinic Cancer Centers-Monroe
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Pontiac, Michigan, Verenigde Staten, 48341
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, Verenigde Staten, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, Verenigde Staten, 48601
- Saint Mary's of Michigan
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Saint Joseph, Michigan, Verenigde Staten, 49085
- Oncology Care Associates PLLC
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Southfield, Michigan, Verenigde Staten, 48075
- Providence Hospital-Southfield Cancer Center
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Warren, Michigan, Verenigde Staten, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Duluth, Minnesota, Verenigde Staten, 55805
- Essentia Health Cancer Center
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Duluth, Minnesota, Verenigde Staten, 55805
- Essentia Health Saint Mary's Medical Center
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Duluth, Minnesota, Verenigde Staten, 55805
- Miller-Dwan Hospital
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Hutchinson, Minnesota, Verenigde Staten, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Verenigde Staten, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Verenigde Staten, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Virginia Piper Cancer Institute
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital
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Saint Paul, Minnesota, Verenigde Staten, 55102
- Saint Joseph's Hospital - Healtheast
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Shakopee, Minnesota, Verenigde Staten, 55379
- Saint Francis Regional Medical Center
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Woodbury, Minnesota, Verenigde Staten, 55125
- Woodwinds Health Campus
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Missouri
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Springfield, Missouri, Verenigde Staten, 65804
- Cancer Research for the Ozarks NCORP
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Springfield, Missouri, Verenigde Staten, 65804
- Mercy Hospital Springfield
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Montana
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Billings, Montana, Verenigde Staten, 59101
- Saint Vincent Healthcare
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Billings, Montana, Verenigde Staten, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Verenigde Staten, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, Verenigde Staten, 59102
- Frontier Cancer Center and Blood Institute-Billings
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Billings, Montana, Verenigde Staten, 59107
- Billings Clinic Cancer Center
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Deaconess Hospital
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Verenigde Staten, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, Verenigde Staten, 59405
- Great Falls Clinic
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Great Falls, Montana, Verenigde Staten, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, Verenigde Staten, 59501
- Northern Montana Hospital
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Helena, Montana, Verenigde Staten, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Verenigde Staten, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Medical Oncology
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Missoula, Montana, Verenigde Staten, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Verenigde Staten, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, Verenigde Staten, 59801
- Community Medical Hospital
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Missoula, Montana, Verenigde Staten, 59802
- Montana Cancer Specialists
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New Jersey
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Mount Holly, New Jersey, Verenigde Staten, 08060
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
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Voorhees, New Jersey, Verenigde Staten, 08043
- Virtua West Jersey Hospital Voorhees
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New York
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Buffalo, New York, Verenigde Staten, 14263
- Roswell Park Cancer Institute
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Glens Falls, New York, Verenigde Staten, 12801
- Glens Falls Hospital
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Middletown, New York, Verenigde Staten, 10940
- Orange Regional Medical Center
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Rochester, New York, Verenigde Staten, 14642
- University of Rochester
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Rochester, New York, Verenigde Staten, 14620
- Highland Hospital
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Rochester, New York, Verenigde Staten, 14623
- Interlakes Foundation Inc-Rochester
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North Carolina
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Kinston, North Carolina, Verenigde Staten, 28501
- Kinston Medical Specialists PA
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North Dakota
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Bismarck, North Dakota, Verenigde Staten, 58501
- Sanford Bismarck Medical Center
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Bismarck, North Dakota, Verenigde Staten, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, Verenigde Staten, 58501
- Saint Alexius Medical Center
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Ohio
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Bowling Green, Ohio, Verenigde Staten, 43402
- Toledo Clinic Cancer Centers-Bowling Green
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Cincinnati, Ohio, Verenigde Staten, 45267
- University of Cincinnati
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Clyde, Ohio, Verenigde Staten, 43410
- North Coast Cancer Care-Clyde
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Dayton, Ohio, Verenigde Staten, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Verenigde Staten, 45409
- Miami Valley Hospital
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Dayton, Ohio, Verenigde Staten, 45415
- Samaritan North Health Center
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Dayton, Ohio, Verenigde Staten, 45405
- Grandview Hospital
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Dayton, Ohio, Verenigde Staten, 45420
- Dayton CCOP
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Dayton, Ohio, Verenigde Staten, 45428
- Veteran Affairs Medical Center
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Elyria, Ohio, Verenigde Staten, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, Verenigde Staten, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, Verenigde Staten, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Verenigde Staten, 45331
- Wayne Hospital
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Kettering, Ohio, Verenigde Staten, 45429
- Kettering Medical Center
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Lima, Ohio, Verenigde Staten, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Verenigde Staten, 43537
- Toledo Clinic Cancer Centers-Maumee
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Maumee, Ohio, Verenigde Staten, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
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Maumee, Ohio, Verenigde Staten, 43537
- Saint Luke's Hospital
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Oregon, Ohio, Verenigde Staten, 43616
- Saint Charles Hospital
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Oregon, Ohio, Verenigde Staten, 43616
- Toledo Clinic Cancer Centers-Oregon
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Sandusky, Ohio, Verenigde Staten, 44870
- North Coast Cancer Care
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Sylvania, Ohio, Verenigde Staten, 43560
- Flower Hospital
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Tiffin, Ohio, Verenigde Staten, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Verenigde Staten, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, Verenigde Staten, 43623
- Toledo Clinic Cancer Centers-Toledo
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Toledo, Ohio, Verenigde Staten, 43614
- University of Toledo
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Toledo, Ohio, Verenigde Staten, 43617
- Toledo Community Hospital Oncology Program CCOP
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Toledo, Ohio, Verenigde Staten, 43606
- The Toledo Hospital/Toledo Children's Hospital
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Toledo, Ohio, Verenigde Staten, 43623
- Mercy Saint Anne Hospital
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Troy, Ohio, Verenigde Staten, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, Verenigde Staten, 43567
- Fulton County Health Center
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Wilmington, Ohio, Verenigde Staten, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Verenigde Staten, 45385
- Greene Memorial Hospital
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Oregon
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Portland, Oregon, Verenigde Staten, 97216
- Adventist Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19111
- Fox Chase Cancer Center
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Wilkes-Barre, Pennsylvania, Verenigde Staten, 18765
- Geisinger South Wilkes-Barre
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South Dakota
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Rapid City, South Dakota, Verenigde Staten, 57701
- Rapid City Regional Hospital
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Texas
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San Antonio, Texas, Verenigde Staten, 78229
- University Hospital
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San Antonio, Texas, Verenigde Staten, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Verenigde Staten, 78209
- Audie L Murphy Veterans Affairs Hospital
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Virginia
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Fredericksburg, Virginia, Verenigde Staten, 22401
- Fredericksburg Oncology Inc
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Washington
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Bellingham, Washington, Verenigde Staten, 98225
- PeaceHealth Saint Joseph Medical Center
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Bremerton, Washington, Verenigde Staten, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
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Kennewick, Washington, Verenigde Staten, 99336
- Kadlec Clinic Hematology and Oncology
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Seattle, Washington, Verenigde Staten, 98195
- University of Washington Medical Center
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Seattle, Washington, Verenigde Staten, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Seattle, Washington, Verenigde Staten, 98104
- Harborview Medical Center
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Seattle, Washington, Verenigde Staten, 98104
- Minor and James Medical PLLC
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Seattle, Washington, Verenigde Staten, 98112
- Group Health Cooperative-Seattle
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Seattle, Washington, Verenigde Staten, 98122-4307
- Swedish Medical Center-First Hill
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Seattle, Washington, Verenigde Staten, 98122
- The Polyclinic
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Seattle, Washington, Verenigde Staten, 98112
- Group Health Cooperative of Puget Sound Oncology Consortium
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Spokane, Washington, Verenigde Staten, 99202
- Cancer Care Northwest - Spokane South
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Wenatchee, Washington, Verenigde Staten, 98801
- Wenatchee Valley Hospital and Clinics
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West Virginia
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Charleston, West Virginia, Verenigde Staten, 25304
- West Virginia University Charleston
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Wisconsin
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Chippewa Falls, Wisconsin, Verenigde Staten, 54729
- Marshfield Clinic-Chippewa Center
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Eau Claire, Wisconsin, Verenigde Staten, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
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Eau Claire, Wisconsin, Verenigde Staten, 54701
- Sacred Heart Hospital
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Marshfield, Wisconsin, Verenigde Staten, 54449
- Marshfield Clinic
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Marshfield, Wisconsin, Verenigde Staten, 54449
- Saint Joseph's Hospital
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Minocqua, Wisconsin, Verenigde Staten, 54548
- Marshfield Clinic-Minocqua Center
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Rhinelander, Wisconsin, Verenigde Staten, 54501
- Marshfield Clinic at James Beck Cancer Center
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Rice Lake, Wisconsin, Verenigde Staten, 54868
- Marshfield Clinic-Rice Lake Center
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Stevens Point, Wisconsin, Verenigde Staten, 54481
- Saint Michael's Hospital
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Wausau, Wisconsin, Verenigde Staten, 54401
- Marshfield Clinic-Wausau Center
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Weston, Wisconsin, Verenigde Staten, 54476
- Diagnostic and Treatment Center
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Weston, Wisconsin, Verenigde Staten, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Verenigde Staten, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Sheridan, Wyoming, Verenigde Staten, 82801
- Welch Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
Correlatieve studies
Correlatieve studies
IV gegeven
Andere namen:
Gegeven PO
Andere namen:
|
|
Actieve vergelijker: 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.
|
Correlatieve studies
Correlatieve studies
Gegeven PO
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression Free Survival
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Response Rate
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Up to 7 years
|
Only adverse events that are possibly, probably or definitely related to study drug are reported.
|
Up to 7 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Charles Blanke, Southwest Oncology Group
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2008
Primaire voltooiing (Werkelijk)
1 juli 2015
Studie voltooiing (Werkelijk)
1 juli 2015
Studieregistratiedata
Eerst ingediend
10 mei 2006
Eerst ingediend dat voldeed aan de QC-criteria
10 mei 2006
Eerst geplaatst (Schatting)
11 mei 2006
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 september 2017
Laatste update ingediend die voldeed aan QC-criteria
15 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata, bindweefsel en zacht weefsel
- Neoplasmata per histologisch type
- Neoplasmata
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Neoplasmata, bindweefsel
- Gastro-intestinale stromale tumoren
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Immunologische factoren
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Proteïnekinaseremmers
- Antilichamen
- Immunoglobulinen
- Bevacizumab
- Antilichamen, monoklonaal
- Antineoplastische middelen, immunologisch
- Imatinib-mesylaat
- Immunoglobuline G
- Endotheliale groeifactoren
Andere studie-ID-nummers
- NCI-2009-00776 (Register-ID: CTRP (Clinical Trial Reporting Program))
- U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
- U10CA180888 (Subsidie/contract van de Amerikaanse NIH)
- CDR0000482236
- S0502 (CTEP)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .