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

15 agosto 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Altro: Studio farmacologico
Studi correlati
Biologico: Bevacizumab
Dato IV
Altri nomi:
  • Avastin
  • Anti-VEGF
  • Anticorpo monoclonale umanizzato anti-VEGF
  • Anti-VEGF rhuMAb
  • Bevacizumab biosimilare BEVZ92
  • Bevacizumab biosimilare BI 695502
  • Immunoglobulina G1 (fattore di crescita endoteliale vascolare monoclonale umano-topo rhuMab-VEGF anti-catena gamma), disolfuro con catena leggera monoclonale umano-topo rhuMab-VEGF, dimero
  • Anticorpo monoclonale anti-VEGF umanizzato ricombinante
  • rhuMab-VEGF
Droga: Imatinib mesilato
Dato PO
Altri nomi:
  • Gleevec
  • CGP 57148
  • CGP57148B
  • Glivec
  • STI 571
  • STI-571
  • STI571
Comparatore attivo: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Altro: Studio farmacologico
Studi correlati
Droga: Imatinib mesilato
Dato PO
Altri nomi:
  • Gleevec
  • CGP 57148
  • CGP57148B
  • Glivec
  • STI 571
  • STI-571
  • STI571

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response Rate
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Up to 7 years
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Up to 7 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Charles Blanke, Southwest Oncology Group

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2008

Completamento primario (Effettivo)

1 luglio 2015

Completamento dello studio (Effettivo)

1 luglio 2015

Date di iscrizione allo studio

Primo inviato

10 maggio 2006

Primo inviato che soddisfa i criteri di controllo qualità

10 maggio 2006

Primo Inserito (Stima)

11 maggio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2009-00776 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U10CA180888 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CDR0000482236
  • S0502 (CTEP)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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