Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery

NCT00041197 | Completed Phase 3

• 4 other identifiers: NCI-2012-02930Z9001CDR0000069452U10CA076001
• Study Type: interventional
• Target: 732
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase III trial is studying imatinib mesylate to see how well it works compared to placebo in treating patients with primary gastrointestinal stromal tumor that has been completely removed by surgery. Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for patients with primary gastrointestinal stromal tumor that has been completely removed by surgery.

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS)

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

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

Secondary Outcomes (2)

• Safety as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  Up to 5 years

• Relationship between genetic and phenotypic characteristics of GIST and clinical outcomes

  Up to 10 years

Study Arms (2)

Arm I (imatinib mesylate)

EXPERIMENTAL

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.

Drug: imatinib mesylate; Other: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

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.

Other: placebo; Other: laboratory biomarker analysis

Interventions

imatinib mesylate DRUG

Given orally (PO)

Also known as: CGP 57148, Gleevec, Glivec

Arm I (imatinib mesylate)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (imatinib mesylate); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

American College of Surgeons Oncology Group

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Corless CL, Ballman KV, Antonescu CR, Kolesnikova V, Maki RG, Pisters PW, Blackstein ME, Blanke CD, Demetri GD, Heinrich MC, von Mehren M, Patel S, McCarter MD, Owzar K, DeMatteo RP. Pathologic and molecular features correlate with long-term outcome after adjuvant therapy of resected primary GI stromal tumor: the ACOSOG Z9001 trial. J Clin Oncol. 2014 May 20;32(15):1563-70. doi: 10.1200/JCO.2013.51.2046. Epub 2014 Mar 17.

  PMID: 24638003 DERIVED

• Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. doi: 10.1016/S0140-6736(09)60500-6. Epub 2009 Mar 18.

  PMID: 19303137 DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Ronald DeMatteo

  American College of Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: April 1, 2007
• Last Updated: July 16, 2013

Record last verified: 2013-06

Locations

US (1)