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

15 août 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

12

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Analyse de biomarqueurs en laboratoire
Études corrélatives
Autre: Étude pharmacologique
Études corrélatives
Biologique: Bévacizumab
Étant donné IV
Autres noms:
  • Avastin
  • Anti-VEGF
  • Anticorps Monoclonal Humanisé Anti-VEGF
  • RhuMAb anti-VEGF
  • Bévacizumab biosimilaire BEVZ92
  • Bévacizumab biosimilaire BI 695502
  • Immunoglobuline G1 (facteur de croissance endothélial vasculaire humain-souris monoclonal rhuMab-VEGF), disulfure avec chaîne légère rhuMab-VEGF monoclonal humain-souris, dimère
  • Anticorps monoclonal anti-VEGF humanisé recombinant
  • rhuMab-VEGF
Médicament: Mésylate d'imatinib
Bon de commande donné
Autres noms:
  • Gleevec
  • CGP 57148
  • CGP57148B
  • Glivec
  • ITS 571
  • STI-571
  • STI571
Comparateur actif: 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.
Autre: Analyse de biomarqueurs en laboratoire
Études corrélatives
Autre: Étude pharmacologique
Études corrélatives
Médicament: Mésylate d'imatinib
Bon de commande donné
Autres noms:
  • Gleevec
  • CGP 57148
  • CGP57148B
  • Glivec
  • ITS 571
  • STI-571
  • STI571

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression Free Survival
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Response Rate
Délai: 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
Délai: 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)
Délai: 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
Délai: Up to 7 years
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Up to 7 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Charles Blanke, Southwest Oncology Group

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2008

Achèvement primaire (Réel)

1 juillet 2015

Achèvement de l'étude (Réel)

1 juillet 2015

Dates d'inscription aux études

Première soumission

10 mai 2006

Première soumission répondant aux critères de contrôle qualité

10 mai 2006

Première publication (Estimation)

11 mai 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCI-2009-00776 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (Subvention/contrat des NIH des États-Unis)
  • U10CA180888 (Subvention/contrat des NIH des États-Unis)
  • CDR0000482236
  • S0502 (CTEP)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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