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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



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