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Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (S0502)

15. august 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
  • Forenede Stater
    • California
      • Berkeley, California, Forenede Stater, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burlingame, California, Forenede Stater, 94010
        • Mills - Peninsula Hospitals
      • Greenbrae, California, Forenede Stater, 94904
        • Marin General Hospital
      • Los Angeles, California, Forenede Stater, 90033
        • USC / Norris Comprehensive Cancer Center
      • Novato, California, Forenede Stater, 94945
        • Sutter Cancer Research Consortium
      • San Francisco, California, Forenede Stater, 94118
        • California Pacific Medical Center-Pacific Campus
      • Vallejo, California, Forenede Stater, 94589
        • Sutter Solano Medical Center/Cancer Center
    • District of Columbia
      • Washington, D.C., District of Columbia, Forenede Stater, 20007
        • MedStar Georgetown University Hospital
    • Georgia
      • Columbus, Georgia, Forenede Stater, 31904
        • John B Amos Cancer Center
      • Savannah, Georgia, Forenede Stater, 31404
        • Memorial University Medical Center
      • Valdosta, Georgia, Forenede Stater, 31603
        • South Georgia Medical Center
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60504
        • Rush - Copley Medical Center
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Forenede Stater, 60631
        • Presence Resurrection Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Joliet, Illinois, Forenede Stater, 60435
        • Joliet Oncology-Hematology Associates Limited
      • La Grange, Illinois, Forenede Stater, 60525
        • Adventist La Grange Memorial Hospital
      • Naperville, Illinois, Forenede Stater, 60540
        • Edward Hospital/Cancer Center
      • Springfield, Illinois, Forenede Stater, 62781
        • Memorial Medical Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Clinic-Urbana Main
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • Franciscan St. Francis Health-Beech Grove
      • Michigan City, Indiana, Forenede Stater, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Hospital and Health Care Services
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Clive, Iowa, Forenede Stater, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Davenport, Iowa, Forenede Stater, 52803
        • Genesis Medical Center - East Campus
      • Davenport, Iowa, Forenede Stater, 52804
        • Genesis Medical Center - West Campus
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, Forenede Stater, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Forenede Stater, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Des Moines, Iowa, Forenede Stater, 50307
        • Mercy Capitol
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Oncology Research Association CCOP
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Salina Regional Health Center
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67214
        • Wichita CCOP
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas - Winfield
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Bixby Medical Center
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Michigan Cancer Research Consortium CCOP
      • Dearborn, Michigan, Forenede Stater, 48124
        • Oakwood Hospital and Medical Center
      • Detroit, Michigan, Forenede Stater, 48236
        • Saint John Hospital and Medical Center
      • Flint, Michigan, Forenede Stater, 48502
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Lansing, Michigan, Forenede Stater, 48912
        • Sparrow Hospital
      • Livonia, Michigan, Forenede Stater, 48154
        • Saint Mary Mercy Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, Forenede Stater, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Pontiac, Michigan, Forenede Stater, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Saint Joseph Mercy Port Huron
      • Saginaw, Michigan, Forenede Stater, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Oncology Care Associates PLLC
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Hospital-Southfield Cancer Center
      • Warren, Michigan, Forenede Stater, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller-Dwan Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, Forenede Stater, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • Saint Joseph's Hospital - Healtheast
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Woodwinds Health Campus
    • Missouri
      • Springfield, Missouri, Forenede Stater, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forenede Stater, 59101
        • Montana Cancer Consortium CCOP
      • Billings, Montana, Forenede Stater, 59102
        • Frontier Cancer Center and Blood Institute-Billings
      • Billings, Montana, Forenede Stater, 59107
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Havre, Montana, Forenede Stater, 59501
        • Northern Montana Hospital
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Forenede Stater, 59801
        • Community Medical Hospital
      • Missoula, Montana, Forenede Stater, 59802
        • Montana Cancer Specialists
    • New Jersey
      • Mount Holly, New Jersey, Forenede Stater, 08060
        • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Virtua West Jersey Hospital Voorhees
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Glens Falls, New York, Forenede Stater, 12801
        • Glens Falls Hospital
      • Middletown, New York, Forenede Stater, 10940
        • Orange Regional Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital
      • Rochester, New York, Forenede Stater, 14623
        • Interlakes Foundation Inc-Rochester
    • North Carolina
      • Kinston, North Carolina, Forenede Stater, 28501
        • Kinston Medical Specialists PA
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Mid Dakota Clinic
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Saint Alexius Medical Center
    • Ohio
      • Bowling Green, Ohio, Forenede Stater, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Clyde, Ohio, Forenede Stater, 43410
        • North Coast Cancer Care-Clyde
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forenede Stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, Forenede Stater, 45405
        • Grandview Hospital
      • Dayton, Ohio, Forenede Stater, 45420
        • Dayton CCOP
      • Dayton, Ohio, Forenede Stater, 45428
        • Veteran Affairs Medical Center
      • Elyria, Ohio, Forenede Stater, 44035
        • Hematology Oncology Center Incorporated
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Hospital
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Kettering, Ohio, Forenede Stater, 45429
        • Kettering Medical Center
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, Forenede Stater, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Maumee, Ohio, Forenede Stater, 43537
        • Saint Luke's Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Coast Cancer Care
      • Sylvania, Ohio, Forenede Stater, 43560
        • Flower Hospital
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, Forenede Stater, 43606
        • The Toledo Hospital/Toledo Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Saint Anne Hospital
      • Troy, Ohio, Forenede Stater, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • Wilmington, Ohio, Forenede Stater, 45177
        • Clinton Memorial Hospital
      • Xenia, Ohio, Forenede Stater, 45385
        • Greene Memorial Hospital
    • Oregon
      • Portland, Oregon, Forenede Stater, 97216
        • Adventist Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18765
        • Geisinger South Wilkes-Barre
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • University Hospital
      • San Antonio, Texas, Forenede Stater, 78229
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78209
        • Audie L Murphy Veterans Affairs Hospital
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Fredericksburg Oncology Inc
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, Forenede Stater, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Kennewick, Washington, Forenede Stater, 99336
        • Kadlec Clinic Hematology and Oncology
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
      • Seattle, Washington, Forenede Stater, 98104
        • Harborview Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Cooperative-Seattle
      • Seattle, Washington, Forenede Stater, 98122-4307
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Forenede Stater, 98122
        • The Polyclinic
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Cooperative of Puget Sound Oncology Consortium
      • Spokane, Washington, Forenede Stater, 99202
        • Cancer Care Northwest - Spokane South
      • Wenatchee, Washington, Forenede Stater, 98801
        • Wenatchee Valley Hospital and Clinics
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • West Virginia University Charleston
    • Wisconsin
      • Chippewa Falls, Wisconsin, Forenede Stater, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Sacred Heart Hospital
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Saint Joseph's Hospital
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Clinic-Minocqua Center
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Marshfield Clinic at James Beck Cancer Center
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Clinic-Rice Lake Center
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Saint Michael's Hospital
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Farmakologisk undersøgelse
Korrelative undersøgelser
Biologisk: Bevacizumab
Givet IV
Andre navne:
  • Avastin
  • Anti-VEGF
  • Anti-VEGF humaniseret monoklonalt antistof
  • Anti-VEGF rhuMAb
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Immunoglobulin G1 (human-mus monoklonal rhuMab-VEGF gammakæde anti-human vaskulær endotelvækstfaktor), disulfid med human-mus monoklonal rhuMab-VEGF let kæde, dimer
  • Rekombinant humaniseret anti-VEGF monoklonalt antistof
  • rhuMab-VEGF
Medicin: Imatinib mesylat
Givet PO
Andre navne:
  • Gleevec
  • CGP 57148
  • CGP57148B
  • Glivec
  • STI 571
  • STI-571
  • STI571
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.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Farmakologisk undersøgelse
Korrelative undersøgelser
Medicin: Imatinib mesylat
Givet PO
Andre navne:
  • Gleevec
  • CGP 57148
  • CGP57148B
  • Glivec
  • STI 571
  • STI-571
  • STI571

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Charles Blanke, Southwest Oncology Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2008

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først indsendt

10. maj 2006

Først indsendt, der opfyldte QC-kriterier

10. maj 2006

Først opslået (Skøn)

11. maj 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2009-00776 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (U.S. NIH-bevilling/kontrakt)
  • U10CA180888 (U.S. NIH-bevilling/kontrakt)
  • CDR0000482236
  • S0502 (CTEP)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner