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TerminatedNCT00324987S0502Updated Sep 14, 2017Results posted

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

A Phase 3 interventional study of Bevacizumab and Imatinib Mesylate in Gastrointestinal Stromal Tumor, sponsored by National Cancer Institute (NCI). Terminated at 192 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

Why this study was terminated
The trial failed to accrue
Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Gastrointestinal Stromal Tumor
03

In context

Gastrointestinal Stromal Tumors

345 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 60 are open to participants now.

This study's enrollment of 12 is below the median of 50 across 253 interventional studies indexed under Gastrointestinal Stromal Tumors.

Browse Gastrointestinal Stromal Tumors studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    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.

    Biological: Bevacizumab · Drug: Imatinib Mesylate · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study

  • Active comparator
    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.

    Drug: Imatinib Mesylate · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study

Interventions

  • BiologicalBevacizumab

    Given IV

    Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF

  • DrugImatinib Mesylate

    Given PO

    Also known as: CGP 57148, CGP57148B, Gleevec, Glivec, STI 571, STI-571, STI571

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPharmacological Study

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    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.

    Time frame: Up to 7 years

Secondary outcomes

  1. Response Rate

    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.

    Time frame: Up to 7 years

  2. Overall Survival

    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.

    Time frame: up to 7 years

  3. Central-review Based Progression-free Survival (CRb-PFS)

    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.

    Time frame: up to 7 years

  4. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Time frame: Up to 7 years

07

Results

Posted Sep 14, 2017
Limitations and caveats
Trial was terminated due to poor accrual. No conclusions should be drawn from the reported data due to the small sample size.

Participant flow

Participant flow — Overall Study
MilestoneImatinib + BevacizumabImatinib
Started66
Completed00
Not completed66
Withdrew: Adverse event21
Withdrew: Withdrawal by subject11
Withdrew: Progression11
Withdrew: Symptomatic deterioration, toxicity, etc23

Outcome measures

SecondaryResponse Rate

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.

Time frame:
Up to 7 years
Reported as:
Count of participants · Participants
Response Rate
ParticipantsImatinib + BevacizumabImatinib
Unconfirmed CR01
Stable/No Response12
Assessment Inadequate22
PrimaryProgression Free Survival

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.

Time frame:
Up to 7 years
Reported as:
Median · months
Progression Free Survival
monthsImatinib + BevacizumabImatinib
Progression Free Survival30 (8 to 62)81 (13 to 81)
SecondaryOverall Survival

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.

Time frame:
up to 7 years
Reported as:
Median · months
Overall Survival
monthsImatinib + BevacizumabImatinib
Overall Survival30 (16 to 30)0 (15 to 0)
SecondaryCentral-review Based Progression-free Survival (CRb-PFS)

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.

Time frame:
up to 7 years

No measurements were reported for this outcome.

SecondaryNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Time frame:
Up to 7 years
Reported as:
Number · Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
ParticipantsImatinib + BevacizumabImatinib
Fatigue (asthenia, lethargy, malaise)10
Hemoglobin10
Hemorrhage, GI - Upper GI NOS10
INR (of prothrombin time)01
Proteinuria10
Thrombosis/embolism (vascular access-related)01

Adverse events

Collected over Up to 7 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Imatinib + Bevacizumab—2/5 (40%)2/5 (40%)
Imatinib—0/6 (0%)5/6 (83.3%)
Most frequent serious events
Most frequent serious events
EventImatinib + BevacizumabImatinib
Hemorrhage, GI - Upper GI NOSGastrointestinal disorders1/50/6
ProteinuriaRenal and urinary disorders1/50/6
Most frequent other events
Showing 10 of 45
Most frequent other events
EventImatinib + BevacizumabImatinib
HemoglobinBlood and lymphatic system disorders2/52/6
NauseaGastrointestinal disorders0/52/6
VomitingGastrointestinal disorders0/52/6
Fatigue (asthenia, lethargy, malaise)General disorders1/52/6
AnorexiaMetabolism and nutrition disorders1/52/6
HypertensionVascular disorders1/52/6
Thyroid function, low (hypothyroidism)Endocrine disorders1/50/6
ConstipationGastrointestinal disorders1/51/6
DiarrheaGastrointestinal disorders1/51/6
Pain - Abdomen NOSGastrointestinal disorders1/51/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Imatinib + BevacizumabImatinibTotal
Median64.7 (49.4 to 82.9)57.9 (44.0 to 68.5)59.9 (44.0 to 82.9)
Sex: Female, Male
Sex: Female, Male(Participants)Imatinib + BevacizumabImatinibTotal
Female358
Male314
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Imatinib + BevacizumabImatinibTotal
Hispanic or Latino000
Not Hispanic or Latino5510
Unknown or Not Reported112
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Imatinib + BevacizumabImatinibTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American000
White549
More than one race000
Unknown or Not Reported011
Performance Status
Performance Status(participants)Imatinib + BevacizumabImatinibTotal
0549
>=1123
Disease Status
Disease Status(participants)Imatinib + BevacizumabImatinibTotal
Measurable5510
Non-measurable112
08

Study locations

192 sites
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
  • Mills - Peninsula Hospitals
    Burlingame, California 94010, United States
  • Marin General Hospital
    Greenbrae, California 94904, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Sutter Cancer Research Consortium
    Novato, California 94945, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94118, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California 94589, United States
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
  • John B Amos Cancer Center
    Columbus, Georgia 31904, United States
  • Memorial University Medical Center
    Savannah, Georgia 31404, United States
  • South Georgia Medical Center
    Valdosta, Georgia 31603, United States
  • Rush - Copley Medical Center
    Aurora, Illinois 60504, United States
  • Presence Resurrection Medical Center
    Chicago, Illinois 60631, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Joliet Oncology-Hematology Associates Limited
    Joliet, Illinois 60435, United States
  • Adventist La Grange Memorial Hospital
    La Grange, Illinois 60525, United States
  • Edward Hospital/Cancer Center
    Naperville, Illinois 60540, United States
  • Memorial Medical Center
    Springfield, Illinois 62781, United States
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Carle Clinic-Urbana Main
    Urbana, Illinois 61801, United States
  • Franciscan St. Francis Health-Beech Grove
    Beech Grove, Indiana 46107, United States
  • Franciscan Saint Anthony Health-Michigan City
    Michigan City, Indiana 46360, United States
  • Reid Hospital and Health Care Services
    Richmond, Indiana 47374, United States
  • McFarland Clinic PC-William R Bliss Cancer Center
    Ames, Iowa 50010, United States
  • Medical Oncology and Hematology Associates-West Des Moines
    Clive, Iowa 50325, United States
  • Genesis Medical Center - East Campus
    Davenport, Iowa 52803, United States
  • Genesis Medical Center - West Campus
    Davenport, Iowa 52804, United States
  • Mercy Capitol
    Des Moines, Iowa 50307, United States
  • Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • Iowa Oncology Research Association CCOP
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates-Des Moines
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates-Laurel
    Des Moines, Iowa 50314, United States
  • Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
  • Siouxland Regional Cancer Center
    Sioux City, Iowa 51101, United States
  • Mercy Medical Center-Sioux City
    Sioux City, Iowa 51104, United States
  • Saint Luke's Regional Medical Center
    Sioux City, Iowa 51104, United States
  • Cancer Center of Kansas - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas - Fort Scott
    Fort Scott, Kansas 66701, United States
  • Cancer Center of Kansas-Independence
    Independence, Kansas 67301, United States
  • Cancer Center of Kansas-Kingman
    Kingman, Kansas 67068, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Cancer Center of Kansas - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas - Parsons
    Parsons, Kansas 67357, United States
  • Cancer Center of Kansas - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas - Salina
    Salina, Kansas 67401, United States
  • Salina Regional Health Center
    Salina, Kansas 67401, United States
  • Cancer Center of Kansas - Wellington
    Wellington, Kansas 67152, United States
  • Associates In Womens Health
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas-Wichita Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas - Main Office
    Wichita, Kansas 67214, United States
  • Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Wichita CCOP
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas - Winfield
    Winfield, Kansas 67156, United States
  • Bixby Medical Center
    Adrian, Michigan 49221, United States
  • Hickman Cancer Center
    Adrian, Michigan 49221, United States
  • Saint Joseph Mercy Hospital
    Ann Arbor, Michigan 48106-0995, United States
  • Michigan Cancer Research Consortium CCOP
    Ann Arbor, Michigan 48106, United States
  • Oakwood Hospital and Medical Center
    Dearborn, Michigan 48124, United States
  • Saint John Hospital and Medical Center
    Detroit, Michigan 48236, United States
  • Hurley Medical Center
    Flint, Michigan 48502, United States
  • Genesys Regional Medical Center-West Flint Campus
    Flint, Michigan 48532, United States
  • Allegiance Health
    Jackson, Michigan 49201, United States
  • Sparrow Hospital
    Lansing, Michigan 48912, United States
  • Saint Mary Mercy Hospital
    Livonia, Michigan 48154, United States
  • Mercy Memorial Hospital
    Monroe, Michigan 48162, United States
  • Toledo Clinic Cancer Centers-Monroe
    Monroe, Michigan 48162, United States
  • Saint Joseph Mercy Oakland
    Pontiac, Michigan 48341, United States
  • Saint Joseph Mercy Port Huron
    Port Huron, Michigan 48060, United States
  • Saint Mary's of Michigan
    Saginaw, Michigan 48601, United States
  • Oncology Care Associates PLLC
    Saint Joseph, Michigan 49085, United States
  • Providence Hospital-Southfield Cancer Center
    Southfield, Michigan 48075, United States
  • Saint John Macomb-Oakland Hospital
    Warren, Michigan 48093, United States
  • Essentia Health Cancer Center
    Duluth, Minnesota 55805, United States
  • Essentia Health Saint Mary's Medical Center
    Duluth, Minnesota 55805, United States
  • Miller-Dwan Hospital
    Duluth, Minnesota 55805, United States
  • Hutchinson Area Health Care
    Hutchinson, Minnesota 55350, United States
  • Meeker County Memorial Hospital
    Litchfield, Minnesota 55355, United States
  • Saint John's Hospital - Healtheast
    Maplewood, Minnesota 55109, United States
  • Virginia Piper Cancer Institute
    Minneapolis, Minnesota 55407, United States
  • Hennepin County Medical Center
    Minneapolis, Minnesota 55415, United States
  • Regions Hospital
    Saint Paul, Minnesota 55101, United States
  • Saint Joseph's Hospital - Healtheast
    Saint Paul, Minnesota 55102, United States
  • Saint Francis Regional Medical Center
    Shakopee, Minnesota 55379, United States
  • Woodwinds Health Campus
    Woodbury, Minnesota 55125, United States
  • Cancer Research for the Ozarks NCORP
    Springfield, Missouri 65804, United States
  • Mercy Hospital Springfield
    Springfield, Missouri 65804, United States
  • Montana Cancer Consortium CCOP
    Billings, Montana 59101, United States
  • Northern Rockies Radiation Oncology Center
    Billings, Montana 59101, United States
  • Saint Vincent Healthcare
    Billings, Montana 59101, United States
  • Frontier Cancer Center and Blood Institute-Billings
    Billings, Montana 59102, United States
  • Billings Clinic Cancer Center
    Billings, Montana 59107, United States
  • Bozeman Deaconess Cancer Center
    Bozeman, Montana 59715, United States
  • Bozeman Deaconess Hospital
    Bozeman, Montana 59715, United States
  • Saint James Community Hospital and Cancer Treatment Center
    Butte, Montana 59701, United States
  • Berdeaux, Donald MD (UIA Investigator)
    Great Falls, Montana 59405, United States
  • Great Falls Clinic
    Great Falls, Montana 59405, United States

Showing the first 100 of 192 sites across 2 countries.

09

References and documents

Publications

  • Blanke CD, Rankin C, Corless C, Eary JF, Mulder K, Okuno SH, George S, Heinrich M. S0502: A SWOG Phase III Randomized Study of Imatinib, With or Without Bevacizumab, in Patients With Untreated Metastatic or Unresectable Gastrointestinal Stromal Tumors. Oncologist. 2015 Dec;20(12):1353-4. doi: 10.1634/theoncologist.2015-0295. Epub 2015 Nov 17. PubMed 26576593 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00324987
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 11, 2006
Start date
Apr 2008
Primary completion
Jul 2015
Completion
Jul 2015
Results posted
Sep 14, 2017
Last update
Sep 14, 2017

Study contacts

Charles Blanke
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Bevacizumab

Other studies in this condition

Gastrointestinal Stromal Tumors →

Other studies from this sponsor

National Cancer Institute (NCI) →

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