Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (S0502)
2017年8月15日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
12
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Berkeley、California、アメリカ、94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burlingame、California、アメリカ、94010
- Mills - Peninsula Hospitals
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Greenbrae、California、アメリカ、94904
- Marin General Hospital
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Los Angeles、California、アメリカ、90033
- USC / Norris Comprehensive Cancer Center
-
Novato、California、アメリカ、94945
- Sutter Cancer Research Consortium
-
San Francisco、California、アメリカ、94118
- California Pacific Medical Center-Pacific Campus
-
Vallejo、California、アメリカ、94589
- Sutter Solano Medical Center/Cancer Center
-
-
District of Columbia
-
Washington, D.C.、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital
-
-
Georgia
-
Columbus、Georgia、アメリカ、31904
- John B Amos Cancer Center
-
Savannah、Georgia、アメリカ、31404
- Memorial University Medical Center
-
Valdosta、Georgia、アメリカ、31603
- South Georgia Medical Center
-
-
Illinois
-
Aurora、Illinois、アメリカ、60504
- Rush - Copley Medical Center
-
Chicago、Illinois、アメリカ、60637
- University of Chicago Comprehensive Cancer Center
-
Chicago、Illinois、アメリカ、60631
- Presence Resurrection Medical Center
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Decatur、Illinois、アメリカ、62526
- Decatur Memorial Hospital
-
Joliet、Illinois、アメリカ、60435
- Joliet Oncology-Hematology Associates Limited
-
La Grange、Illinois、アメリカ、60525
- Adventist La Grange Memorial Hospital
-
Naperville、Illinois、アメリカ、60540
- Edward Hospital/Cancer Center
-
Springfield、Illinois、アメリカ、62781
- Memorial Medical Center
-
Urbana、Illinois、アメリカ、61801
- Carle Cancer Center
-
Urbana、Illinois、アメリカ、61801
- Carle Clinic-Urbana Main
-
-
Indiana
-
Beech Grove、Indiana、アメリカ、46107
- Franciscan St. Francis Health-Beech Grove
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Michigan City、Indiana、アメリカ、46360
- Franciscan Saint Anthony Health-Michigan City
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Richmond、Indiana、アメリカ、47374
- Reid Hospital and Health Care Services
-
-
Iowa
-
Ames、Iowa、アメリカ、50010
- McFarland Clinic PC-William R Bliss Cancer Center
-
Clive、Iowa、アメリカ、50325
- Medical Oncology and Hematology Associates-West Des Moines
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Davenport、Iowa、アメリカ、52803
- Genesis Medical Center - East Campus
-
Davenport、Iowa、アメリカ、52804
- Genesis Medical Center - West Campus
-
Des Moines、Iowa、アメリカ、50309
- Iowa Methodist Medical Center
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Des Moines、Iowa、アメリカ、50314
- Mercy Medical Center - Des Moines
-
Des Moines、Iowa、アメリカ、50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines、Iowa、アメリカ、50316
- Iowa Lutheran Hospital
-
Des Moines、Iowa、アメリカ、50314
- Medical Oncology and Hematology Associates-Laurel
-
Des Moines、Iowa、アメリカ、50307
- Mercy Capitol
-
Des Moines、Iowa、アメリカ、50309
- Iowa Oncology Research Association CCOP
-
Sioux City、Iowa、アメリカ、51101
- Siouxland Regional Cancer Center
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Sioux City、Iowa、アメリカ、51104
- Saint Luke's Regional Medical Center
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Sioux City、Iowa、アメリカ、51104
- Mercy Medical Center-Sioux City
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-
Kansas
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Chanute、Kansas、アメリカ、66720
- Cancer Center of Kansas - Chanute
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Dodge City、Kansas、アメリカ、67801
- Cancer Center of Kansas - Dodge City
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El Dorado、Kansas、アメリカ、67042
- Cancer Center of Kansas - El Dorado
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Fort Scott、Kansas、アメリカ、66701
- Cancer Center of Kansas - Fort Scott
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Independence、Kansas、アメリカ、67301
- Cancer Center of Kansas-Independence
-
Kingman、Kansas、アメリカ、67068
- Cancer Center of Kansas-Kingman
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Lawrence、Kansas、アメリカ、66044
- Lawrence Memorial Hospital
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Newton、Kansas、アメリカ、67114
- Cancer Center of Kansas - Newton
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Parsons、Kansas、アメリカ、67357
- Cancer Center of Kansas - Parsons
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Pratt、Kansas、アメリカ、67124
- Cancer Center of Kansas - Pratt
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Salina、Kansas、アメリカ、67401
- Salina Regional Health Center
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Salina、Kansas、アメリカ、67401
- Cancer Center of Kansas - Salina
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Wellington、Kansas、アメリカ、67152
- Cancer Center of Kansas - Wellington
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Wichita、Kansas、アメリカ、67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita、Kansas、アメリカ、67208
- Associates In Womens Health
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Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas - Main Office
-
Wichita、Kansas、アメリカ、67214
- Via Christi Regional Medical Center
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Wichita、Kansas、アメリカ、67214
- Wichita CCOP
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Winfield、Kansas、アメリカ、67156
- Cancer Center of Kansas - Winfield
-
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Michigan
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Adrian、Michigan、アメリカ、49221
- Bixby Medical Center
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Adrian、Michigan、アメリカ、49221
- Hickman Cancer Center
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Ann Arbor、Michigan、アメリカ、48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor、Michigan、アメリカ、48106
- Michigan Cancer Research Consortium CCOP
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Dearborn、Michigan、アメリカ、48124
- Oakwood Hospital and Medical Center
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Detroit、Michigan、アメリカ、48236
- Saint John Hospital and Medical Center
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Flint、Michigan、アメリカ、48502
- Hurley Medical Center
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Flint、Michigan、アメリカ、48532
- Genesys Regional Medical Center-West Flint Campus
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Jackson、Michigan、アメリカ、49201
- Allegiance Health
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Lansing、Michigan、アメリカ、48912
- Sparrow Hospital
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Livonia、Michigan、アメリカ、48154
- Saint Mary Mercy Hospital
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Monroe、Michigan、アメリカ、48162
- Mercy Memorial Hospital
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Monroe、Michigan、アメリカ、48162
- Toledo Clinic Cancer Centers-Monroe
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Pontiac、Michigan、アメリカ、48341
- Saint Joseph Mercy Oakland
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Port Huron、Michigan、アメリカ、48060
- Saint Joseph Mercy Port Huron
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Saginaw、Michigan、アメリカ、48601
- Saint Mary's of Michigan
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Saint Joseph、Michigan、アメリカ、49085
- Oncology Care Associates PLLC
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Southfield、Michigan、アメリカ、48075
- Providence Hospital-Southfield Cancer Center
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Warren、Michigan、アメリカ、48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Duluth、Minnesota、アメリカ、55805
- Essentia Health Cancer Center
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Duluth、Minnesota、アメリカ、55805
- Essentia Health Saint Mary's Medical Center
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Duluth、Minnesota、アメリカ、55805
- Miller-Dwan Hospital
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Hutchinson、Minnesota、アメリカ、55350
- Hutchinson Area Health Care
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Litchfield、Minnesota、アメリカ、55355
- Meeker County Memorial Hospital
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Maplewood、Minnesota、アメリカ、55109
- Saint John's Hospital - Healtheast
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Minneapolis、Minnesota、アメリカ、55415
- Hennepin County Medical Center
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Minneapolis、Minnesota、アメリカ、55407
- Virginia Piper Cancer Institute
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Saint Paul、Minnesota、アメリカ、55101
- Regions Hospital
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Saint Paul、Minnesota、アメリカ、55102
- Saint Joseph's Hospital - Healtheast
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Shakopee、Minnesota、アメリカ、55379
- Saint Francis Regional Medical Center
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Woodbury、Minnesota、アメリカ、55125
- Woodwinds Health Campus
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Missouri
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Springfield、Missouri、アメリカ、65804
- Cancer Research for the Ozarks NCORP
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Springfield、Missouri、アメリカ、65804
- Mercy Hospital Springfield
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Montana
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Billings、Montana、アメリカ、59101
- Saint Vincent Healthcare
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Billings、Montana、アメリカ、59101
- Northern Rockies Radiation Oncology Center
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Billings、Montana、アメリカ、59101
- Montana Cancer Consortium CCOP
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Billings、Montana、アメリカ、59102
- Frontier Cancer Center and Blood Institute-Billings
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Billings、Montana、アメリカ、59107
- Billings Clinic Cancer Center
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Bozeman、Montana、アメリカ、59715
- Bozeman Deaconess Hospital
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Bozeman、Montana、アメリカ、59715
- Bozeman Deaconess Cancer Center
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Butte、Montana、アメリカ、59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls、Montana、アメリカ、59405
- Great Falls Clinic
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Great Falls、Montana、アメリカ、59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre、Montana、アメリカ、59501
- Northern Montana Hospital
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Helena、Montana、アメリカ、59601
- Saint Peter's Community Hospital
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Kalispell、Montana、アメリカ、59901
- Kalispell Regional Medical Center
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Kalispell、Montana、アメリカ、59901
- Glacier Oncology PLLC
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Kalispell、Montana、アメリカ、59901
- Kalispell Medical Oncology
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Missoula、Montana、アメリカ、59802
- Saint Patrick Hospital - Community Hospital
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Missoula、Montana、アメリカ、59804
- Guardian Oncology and Center for Wellness
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Missoula、Montana、アメリカ、59801
- Community Medical Hospital
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Missoula、Montana、アメリカ、59802
- Montana Cancer Specialists
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New Jersey
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Mount Holly、New Jersey、アメリカ、08060
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
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Voorhees、New Jersey、アメリカ、08043
- Virtua West Jersey Hospital Voorhees
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New York
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Buffalo、New York、アメリカ、14263
- Roswell Park Cancer Institute
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Glens Falls、New York、アメリカ、12801
- Glens Falls Hospital
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Middletown、New York、アメリカ、10940
- Orange Regional Medical Center
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Rochester、New York、アメリカ、14642
- University of Rochester
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Rochester、New York、アメリカ、14620
- Highland Hospital
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Rochester、New York、アメリカ、14623
- Interlakes Foundation Inc-Rochester
-
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North Carolina
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Kinston、North Carolina、アメリカ、28501
- Kinston Medical Specialists PA
-
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North Dakota
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Bismarck、North Dakota、アメリカ、58501
- Sanford Bismarck Medical Center
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Bismarck、North Dakota、アメリカ、58501
- Mid Dakota Clinic
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Bismarck、North Dakota、アメリカ、58501
- Saint Alexius Medical Center
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Ohio
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Bowling Green、Ohio、アメリカ、43402
- Toledo Clinic Cancer Centers-Bowling Green
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Cincinnati、Ohio、アメリカ、45267
- University of Cincinnati
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Clyde、Ohio、アメリカ、43410
- North Coast Cancer Care-Clyde
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Dayton、Ohio、アメリカ、45406
- Good Samaritan Hospital - Dayton
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Dayton、Ohio、アメリカ、45409
- Miami Valley Hospital
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Dayton、Ohio、アメリカ、45415
- Samaritan North Health Center
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Dayton、Ohio、アメリカ、45405
- Grandview Hospital
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Dayton、Ohio、アメリカ、45420
- Dayton CCOP
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Dayton、Ohio、アメリカ、45428
- Veteran Affairs Medical Center
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Elyria、Ohio、アメリカ、44035
- Hematology Oncology Center Incorporated
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Findlay、Ohio、アメリカ、45840
- Blanchard Valley Hospital
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Franklin、Ohio、アメリカ、45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville、Ohio、アメリカ、45331
- Wayne Hospital
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Kettering、Ohio、アメリカ、45429
- Kettering Medical Center
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Lima、Ohio、アメリカ、45804
- Lima Memorial Hospital
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Maumee、Ohio、アメリカ、43537
- Toledo Clinic Cancer Centers-Maumee
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Maumee、Ohio、アメリカ、43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Maumee、Ohio、アメリカ、43537
- Saint Luke's Hospital
-
Oregon、Ohio、アメリカ、43616
- Saint Charles Hospital
-
Oregon、Ohio、アメリカ、43616
- Toledo Clinic Cancer Centers-Oregon
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Sandusky、Ohio、アメリカ、44870
- North Coast Cancer Care
-
Sylvania、Ohio、アメリカ、43560
- Flower Hospital
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Tiffin、Ohio、アメリカ、44883
- Mercy Hospital of Tiffin
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Toledo、Ohio、アメリカ、43608
- Saint Vincent Mercy Medical Center
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Toledo、Ohio、アメリカ、43623
- Toledo Clinic Cancer Centers-Toledo
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Toledo、Ohio、アメリカ、43614
- University of Toledo
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Toledo、Ohio、アメリカ、43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo、Ohio、アメリカ、43606
- The Toledo Hospital/Toledo Children's Hospital
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Toledo、Ohio、アメリカ、43623
- Mercy Saint Anne Hospital
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Troy、Ohio、アメリカ、45373
- Upper Valley Medical Center
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Wauseon、Ohio、アメリカ、43567
- Fulton County Health Center
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Wilmington、Ohio、アメリカ、45177
- Clinton Memorial Hospital
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Xenia、Ohio、アメリカ、45385
- Greene Memorial Hospital
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Oregon
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Portland、Oregon、アメリカ、97216
- Adventist Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19111
- Fox Chase Cancer Center
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Wilkes-Barre、Pennsylvania、アメリカ、18765
- Geisinger South Wilkes-Barre
-
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South Dakota
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Rapid City、South Dakota、アメリカ、57701
- Rapid City Regional Hospital
-
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Texas
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San Antonio、Texas、アメリカ、78229
- University Hospital
-
San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center at San Antonio
-
San Antonio、Texas、アメリカ、78209
- Audie L Murphy Veterans Affairs Hospital
-
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Virginia
-
Fredericksburg、Virginia、アメリカ、22401
- Fredericksburg Oncology Inc
-
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Washington
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Bellingham、Washington、アメリカ、98225
- PeaceHealth Saint Joseph Medical Center
-
Bremerton、Washington、アメリカ、98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
-
Kennewick、Washington、アメリカ、99336
- Kadlec Clinic Hematology and Oncology
-
Seattle、Washington、アメリカ、98195
- University of Washington Medical Center
-
Seattle、Washington、アメリカ、98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
Seattle、Washington、アメリカ、98104
- Harborview Medical Center
-
Seattle、Washington、アメリカ、98104
- Minor and James Medical PLLC
-
Seattle、Washington、アメリカ、98112
- Group Health Cooperative-Seattle
-
Seattle、Washington、アメリカ、98122-4307
- Swedish Medical Center-First Hill
-
Seattle、Washington、アメリカ、98122
- The Polyclinic
-
Seattle、Washington、アメリカ、98112
- Group Health Cooperative of Puget Sound Oncology Consortium
-
Spokane、Washington、アメリカ、99202
- Cancer Care Northwest - Spokane South
-
Wenatchee、Washington、アメリカ、98801
- Wenatchee Valley Hospital and Clinics
-
-
West Virginia
-
Charleston、West Virginia、アメリカ、25304
- West Virginia University Charleston
-
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Wisconsin
-
Chippewa Falls、Wisconsin、アメリカ、54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire、Wisconsin、アメリカ、54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Eau Claire、Wisconsin、アメリカ、54701
- Sacred Heart Hospital
-
Marshfield、Wisconsin、アメリカ、54449
- Marshfield Clinic
-
Marshfield、Wisconsin、アメリカ、54449
- Saint Joseph's Hospital
-
Minocqua、Wisconsin、アメリカ、54548
- Marshfield Clinic-Minocqua Center
-
Rhinelander、Wisconsin、アメリカ、54501
- Marshfield Clinic at James Beck Cancer Center
-
Rice Lake、Wisconsin、アメリカ、54868
- Marshfield Clinic-Rice Lake Center
-
Stevens Point、Wisconsin、アメリカ、54481
- Saint Michael's Hospital
-
Wausau、Wisconsin、アメリカ、54401
- Marshfield Clinic-Wausau Center
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Weston、Wisconsin、アメリカ、54476
- Diagnostic and Treatment Center
-
Weston、Wisconsin、アメリカ、54476
- Marshfield Clinic - Weston Center
-
Wisconsin Rapids、Wisconsin、アメリカ、54494
- Marshfield Clinic - Wisconsin Rapids Center
-
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Wyoming
-
Sheridan、Wyoming、アメリカ、82801
- Welch Cancer Center
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-
-
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Alberta
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Calgary、Alberta、カナダ、T2N 4N2
- Tom Baker Cancer Centre
-
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British Columbia
-
Vancouver、British Columbia、カナダ、V5Z 4E6
- BCCA-Vancouver Cancer Centre
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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相関研究
相関研究
与えられた IV
他の名前：
与えられたPO
他の名前：
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アクティブコンパレータ：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.
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相関研究
相関研究
与えられたPO
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Progression Free Survival
時間枠：Up to 7 years
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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.
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Up to 7 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Response Rate
時間枠：Up to 7 years
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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.
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Up to 7 years
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Overall Survival
時間枠：up to 7 years
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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.
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up to 7 years
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Central-review Based Progression-free Survival (CRb-PFS)
時間枠：up to 7 years
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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.
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up to 7 years
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Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
時間枠：Up to 7 years
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Only adverse events that are possibly, probably or definitely related to study drug are reported.
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Up to 7 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Charles Blanke、Southwest Oncology Group
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年4月1日
一次修了 (実際)
2015年7月1日
研究の完了 (実際)
2015年7月1日
試験登録日
最初に提出
2006年5月10日
QC基準を満たした最初の提出物
2006年5月10日
最初の投稿 (見積もり)
2006年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2017年9月14日
QC基準を満たした最後の更新が送信されました
2017年8月15日
最終確認日
2017年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2009-00776 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- U10CA032102 (米国 NIH グラント/契約)
- U10CA180888 (米国 NIH グラント/契約)
- CDR0000482236
- S0502 (CTEP)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。