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A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevecâ„¢) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumor

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Trial Information

A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevecâ„¢) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)


PRIMARY OBJECTIVES:

I. To determine whether patients with resected primary gastrointestinal stromal tumor (GIST)
who are randomized to the STI571 (imatinib mesylate) Arm have longer recurrence-free
survival as compared to the patients randomized to the placebo Arm.

SECONDARY OBJECTIVES:

I. To ascertain whether patients with resected primary GIST who are randomized to the STI571
Arm have longer survival as compared to the patients randomized to the placebo Arm.

II. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and if the
patient develops recurrence), blood specimens (before therapy with STI571), and serum
specimens (before therapy with STI571, after completing therapy with STI571, and if the
patient develops recurrence) for scientific correlative analyses.

III. To assess the safety/efficacy of oral STI571 therapy in the adjuvant setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral imatinib mesylate (Gleevec; STI571) once daily. Treatment
continues for 1 year in the absence of unacceptable toxicity. Patients who develop a
recurrence during the year of initial treatment receive imatinib mesylate (Gleevec; STI571)
at an increased dose. Patients who develop a recurrence after the year of initial treatment
restart imatinib mesylate (Gleevec; STI571) and continue taking the drug at the discretion
of the principal investigator.

ARM II: Patients receive oral placebo once daily. Treatment continues for 1 year in the
absence of unacceptable toxicity. Patients who develop a recurrence at any time discontinue
placebo and crossover to arm I. Treatment on arm I continues at the discretion of the
principal investigator.

Patients are followed every 3 months for 2 years, then every 6 months for 10 years.


Inclusion Criteria:



- Patient must have an ECOG/Zubrod performance status of =< 2

- Patient must have a histologic diagnosis of primary GIST (without peritoneal or
distant metastasis) that expresses Kit protein by immunohistochemistry and have tumor
size >= 3cm in maximum dimension

- Patient must have undergone complete gross resection (includes R0 [negative
microscopic margins] and R1 [positive microscopic margins]) of a primary GIST within
70 days prior to registration

- Patient must have a chest x-ray completed within 28 days prior to registration; NOTE:
Chest CT within 28 days prior to registration can be used in lieu of chest x-ray

- Patient must have a post-operative CT scan with IV and PO contrast or MRI with
contrast (if allergic to CT contrast) of abdomen and pelvis within 28 days prior to
registration

- Creatinine =< 1.5 times the institution ULN

- WBC >= 2,000/mm^3

- Platelets >= 100,000/mm^3

- Total Bilirubin =< 1.5 times the institution ULN; NOTE: Patients with elevated
bilirubin secondary to Gilbert's disease are eligible to participate in the study

- AST =< 2.5 times the institution ULN

- ALT =< 2.5 times the institution ULN

- Female of childbearing potential must have negative serum pregnancy test; NOTE:
Post-menopausal women must be amenorrheic for at least 12 months to be deemed not of
reproductive potential

- Patient or the patient's legally acceptable representative must provide a signed and
dated written informed consent prior to registration and any study-related procedures

- Patient must provide written authorization to allow the use and disclosure of their
protected health information; NOTE: This may be obtained in either the study-specific
informed consent or in a separate authorization form and must be obtained from the
patient prior to study registration (non-US sites are exempt from HIPAA regulations)

- If patient is a cancer survivor, ALL of the following criteria apply:

- Patient has undergone potentially curative therapy for all prior malignancies

- No evidence of any prior malignancies for at least 5 years with no evidence of
recurrence (except for effectively treated basal cell or squamous carcinoma of
the skin, carcinoma in-situ of the cervix that has been effectively treated by
surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral
breast treated by surgery alone)

- Patient is deemed by their treating physician to be at low risk for recurrence
from prior malignancies

Exclusion Criteria:

- Patient has received post-operative chemotherapy

- Patient has received post-operative radiation therapy

- Patient has received post-operative investigational treatment

- Patient has received prior therapy with STI571

- Patient has had an active infection requiring antibiotics within 14 days prior to
registration

- Patient has objective evidence of residual disease on the postoperative CT scan or
MRI of the abdomen or pelvis

- Patient, if female and breastfeeding; NOTE: It is not known whether STI571or its
metabolites are excreted in human milk; however, in lactating female rats
administered 100mg/kg, a dose approximately equal to the maximum clinical dose of
800mg/day based on body surface area, STI571 and /or its metabolites were extensively
excreted in milk; it is estimated that approximately 1.5% of a maternal dose is
excreted into milk, which is equivalent to a dose to the infant of 30% the maternal
dose per unit body weight; women should be advised against breastfeeding while taking
STI571

- Patient has New York Heart Association class 3 or 4 cardiac disease

- Patient is taking full dose warfarin; NOTE: The use of mini-dose warfarin (1mg orally
per day) for prevention of central line-associated deep venous thrombosis is
permitted

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Recurrence-free survival (RFS)

Outcome Description:

An O'Brien-Fleming bound will be used to stop the trial early for superiority of the STI571 arm.

Outcome Time Frame:

From date of resection to the date of first observation of recurrence, assessed up to 10 years

Safety Issue:

No

Principal Investigator

Ronald DeMatteo

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Surgeons

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02930

NCT ID:

NCT00041197

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors

Name

Location

American College of Surgeons Oncology GroupDurham, North Carolina  27705