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A Phase III Randomized Study of Imatinib, With or Without Bevacizumab (NSC-704865), in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors

Phase 3
18 Years
Open (Enrolling)
Gastrointestinal Stromal Tumor

Thank you

Trial Information

A Phase III Randomized Study of Imatinib, With or Without Bevacizumab (NSC-704865), in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors


I. Compare the progression-free survival of patients with metastatic or unresectable
gastrointestinal stromal tumor treated with imatinib mesylate with vs without bevacizumab.

II. Compare the response probabilities (in patients with measurable disease) and overall
survival rates in patients treated with these regimens.

III. Compare the frequency and severity of toxicities associated with these regimens in
these patients.

IV. Correlate soluble vascular endothelial growth factor (VEGF), VEGF-D, VEGF receptor
(VEGFR)-1, VEGFR-2, angiopoietin-2, platelet-derived growth factor receptor (PDGFR)-AA and
PDGFR-BB levels, positron-emission tomography imaging, and immunohistochemistry for p16,
VEGF, and VEGFR with kinase mutation status and clinical outcomes.

V. Examine the pharmacokinetics of imatinib mesylate with single nucleotide polymorphisms
involving the ABCG2 and CYP3A4 genes, as well as other genes that are reported to influence
the absorption, distribution, metabolism, and elimination of imatinib mesylate.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Zubrod performance status (0 vs 1-3) and disease status (measurable vs non-measurable).
Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral imatinib mesylate once daily on days 1-21 and bevacizumab IV
over 30-90 minutes on day 1.

ARM II: Patients receive oral imatinib mesylate once daily on days 1-21.

In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

Blood* is obtained at baseline, periodically during study treatment, and at disease
progression. Blood is analyzed for angiogenesis-related soluble factors, kinase genotyping,
pharmacokinetics, and pharmacogenomics.

[Note: *Samples are no longer considered mandatory for study as of 5/29/2009.]

After completion of study treatment, patients are followed periodically for up to 7 years.

Inclusion Criteria


- Histologically confirmed gastrointestinal stromal tumor (GIST)

- Metastatic or unresectable disease

- Determined to be unresectable for cure

- Measurable and/or nonmeasurable disease by MRI or CT scan

- No known brain metastasis

- Zubrod performance status 0-3

- Platelet count >= 100,000/mm^3

- Absolute neutrophil count >=1,000/mm^3

- Hemoglobin >= 9 g/dL (transfusion allowed)

- Bilirubin =< 2.0 times upper limit of normal (ULN)

- SGOT/SGPT =< 2.5 times ULN (5 times ULN with liver involvement)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for up to 6
months after completion of study treatment

- No cerebrovascular accident, transient ischemic attack, myocardial infarction, or
unstable angina within the past 6 months

- No serious cardiac arrhythmia requiring medication

- No New York Heart Association class II-IV congestive heart failure

- No clinically significant peripheral vascular disease

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- No contraindication to oral medications (e.g., severe dysphagia)

- G- or J-tubes allowed

- No history of hypertension unless well controlled (i.e., blood pressure < 160/90 mm
Hg) and on a stable regimen of antihypertensive therapy

- No serious nonhealing wound, ulcer, or bone fracture

- No other prior malignancy except for any of the following: adequately treated basal
cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage
I or II cancer that is currently in complete remission; any other cancer for which
the patient has been disease free for >= 5 years

- No significant traumatic injury in the past 28 days

- Recovered from prior therapy

- At least 28 days since prior chemotherapy

- At least 28 days since prior radiotherapy

- Evidence of progressive disease within the radiation field or disease outside the
radiation field

- No prior bevacizumab or other agents targeting vascular endothelial growth factor
(VEGF), VEGF receptor, or platelet-derived growth factor receptor (PDGFR) for
advanced disease

- These agents may have been used in the adjuvant setting provided no recurrence for >=
12 months after completion of therapy

- More than 28 days since prior major surgery or open biopsy

- No anticipated need for major surgery

- More than 7 days since prior fine-needle aspiration or core biopsies

- More than 7 days since prior procedure to place a portacath

- No other concurrent anticancer biologic agents, chemotherapy, radiotherapy, or any
other anticancer agents

- No concurrent therapeutic warfarin for anticoagulation

- Concurrent low-molecular weight heparin or other agents for therapeutic
anticoagulation or mini-dose warfarin for prophylaxis allowed

- No other concurrent investigational agents

- Creatinine =< 1.5 times ULN

- Urine protein:creatinine ratio < 1

- INR =< 1.5

- PTT normal

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Investigator-assessed progression-free survival

Outcome Description:

Analyzed using stratified logrank statistic, calculated from the stratified Cox-model.

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Charles Blanke

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors



Roswell Park Cancer Institute Buffalo, New York  14263
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
University of Washington Medical Center Seattle, Washington  98195-6043
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
Rapid City Regional Hospital Rapid City, South Dakota  57709
Marshfield Clinic Marshfield, Wisconsin  54449
Sutter Health Western Division Cancer Research Group Greenbrae, California  94904
South Georgia Medical Center Valdosta, Georgia  31603
Virginia Piper Cancer Institute Minneapolis, Minnesota  55407
Via Christi Regional Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
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Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Medical Oncology Kalispell, Montana  59901
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Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Welch Cancer Center Sheridan, Wyoming  82801
Sutter Solano Medical Center Vallejo, California  94589
Genesis Medical Center - West Campus Davenport, Iowa  52804
Salina Regional Health Center Salina, Kansas  67401
Community Cancer Center of Monroe Monroe, Michigan  48162
Bismarck Cancer Center Bismarck, North Dakota  58501
Grandview Hospital Dayton, Ohio  45405
Lima Memorial Hospital Lima, Ohio  45804
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Fulton County Health Center Wauseon, Ohio  43567
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Bixby Medical Center Adrian, Michigan  49221
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Saint Luke's Hospital Maumee, Ohio  43537
Miami Valley Hospital Dayton, Ohio  45409
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Wayne Hospital Greenville, Ohio  45331
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Diagnostic and Treatment Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Greene Memorial Hospital Xenia, Ohio  45385
Memorial Medical Center Springfield, Illinois  62781
La Grange Memorial Hospital La Grange, Illinois  60525
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Woodwinds Health Campus Woodbury, Minnesota  55125
Hennepin County Medical Center Minneapolis, Minnesota  
University of Rochester Rochester, New York  14642
Glens Falls Hospital Glens Falls, New York  12801
California Pacific Medical Center San Francisco, California  94115
Mid Dakota Clinic Bismarck, North Dakota  58501
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Flower Hospital Sylvania, Ohio  43560-2197
Providence Hospital Southfield, Michigan  48075
Decatur Memorial Hospital Decatur, Illinois  62526
Montana Cancer Specialists Missoula, Montana  59807-7877
Memorial Health University Medical Center Savannah, Georgia  31404
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
University of Southern California Los Angeles, California  90033
University of Cincinnati Cincinnati, Ohio  45267-0502
Mills - Peninsula Hospitals Burlingame, California  94010
Lombardi Comprehensive Cancer Center at Georgetown University Washington, District of Columbia  20057
John B Amos Cancer Center Columbus, Georgia  31904
Rush - Copley Medical Center Aurora, Illinois  60504
Resurrection Healthcare Chicago, Illinois  60631
Joliet Oncology-Hematology Associates Limited Joliet, Illinois  60435
Carle Clinic-Urbana Main Urbana, Illinois  61801
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Saint Anthony Memorial Health Center Michigan City, Indiana  46360
Reid Hospital and Health Care Services Richmond, Indiana  47374
McFarland Clinic Ames, Iowa  50010
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Genesis Medical Center - East Campus Davenport, Iowa  52803
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Capitol Des Moines, Iowa  50307
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Hickman Cancer Center Adrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital Monroe, Michigan  48162
Saint Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Saint Joseph Mercy Port Huron Port Huron, Michigan  48060
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Miller-Dwan Hospital Duluth, Minnesota  55805
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Saint Joseph's Hospital - Healtheast Saint Paul, Minnesota  55102
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Springfield, Missouri  65802
Saint John's Hospital Springfield, Missouri  65804
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Billings Clinic Billings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly, New Jersey  08060
Virtua West Jersey Hospital Voorhees Voorhees, New Jersey  08043
Orange Regional Medical Center Middletown, New York  10940
Interlakes Foundation Inc-Rochester Rochester, New York  14623
Highland Hospital Rochester, New York  14620
Kinston Medical Specialists PA Kinston, North Carolina  28501
Saint Alexius Medical Center Bismarck, North Dakota  58501
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Veteran Affairs Medical Center Dayton, Ohio  45428
Hematology Oncology Center Incorporated Elyria, Ohio  44035
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee, Ohio  43537
Saint Charles Hospital Oregon, Ohio  43616
North Coast Cancer Care Sandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOP Toledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy Hospital Toledo, Ohio  43623
University of Toledo Toledo, Ohio  43614
Saint Vincent Mercy Medical Center Toledo, Ohio  43608
Upper Valley Medical Center Troy, Ohio  45373
Audie L Murphy Veterans Affairs Hospital San Antonio, Texas  78209
University Hospital San Antonio, Texas  78229
Fredericksburg Oncology Inc Fredericksburg, Virginia  22401
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Sacred Heart Hospital Eau Claire, Wisconsin  54701
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin  54548
Marshfield Clinic at James Beck Cancer Center Rhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake Center Rice Lake, Wisconsin  54868
Saint Michael's Hospital Stevens Point, Wisconsin  54481
Marshfield Clinic-Wausau Center Wausau, Wisconsin  54401
Oncology Care Associates PLLC St. Joseph, Michigan  49085
Marin General Hospital Greenbrae, California  94904
North Coast Cancer Care-Clyde Clyde, Ohio  43410
West Virginia University Charleston Charleston, West Virginia  25304
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California  94704
Carle Foundation - Carle Cancer Center Urbana, Illinois  61801
Southwest Oncology Group San Antonio, Texas  78245
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Essentia Health Saint Mary's Medical Center Duluth, Minnesota  55805
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Edward Hospital/Cancer Center Naperville, Illinois  60540
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623
Geisinger South Wilkes-Barre Wilkes-Barre, Pennsylvania  18765