NCT00025246

Brief Summary

This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

February 20, 2013

Status Verified

January 1, 2013

Enrollment Period

6.2 years

First QC Date

October 11, 2001

Last Update Submit

February 19, 2013

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (1)

  • Determination whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with imatinib mesylate have prolonged survival compared to historical controls

    Up to 5 years

Secondary Outcomes (4)

  • Prevalence of recurrence free survival

    2 years

  • Prevalence of recurrence

    5 years

  • Overall survival

    Up to 5 years

  • Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria

    Up to 10 years

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection. Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity.

Drug: imatinib mesylateOther: laboratory biomarker analysis

Interventions

imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (imatinib mesylate)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must have an ECOG/Zubrod performance status of ≤ 2
  • Patient must have a diagnosis of high-risk primary GIST; NOTE: High risk is defined as tumor size ≥ 10 cm in maximum dimension, or the presence of tumor rupture before or during surgery, intraperitoneal hemorrhage or multifocal (\< 5) intraperitoneal tumors
  • Patient must have undergone complete gross resection (includes R0 \[negative microscopic margins\] and R1 \[positive microscopic margins\] resections) of a primary GIST within 70 days prior to registration
  • Patient must have a histologic diagnosis of GIST that is confirmed by central pathology review
  • Patient's tumor must stain positive for the Kit receptor tyrosine kinase on immunohistochemistry as determined by the central pathologist using the Dako (Dako Corp., Carpinteria, CA) anti-CD 117 antibody
  • Patient must have a chest x-ray completed within 28 days prior to registration
  • 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
  • Platelet ≥ 100,000/mm\^3
  • Total bilirubin ≤ 1.5 times the institution ULN
  • AST and ALT ≤ 2.5 times the institution ULN
  • Female of childbearing potential must have negative serum pregnancy test
  • 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
  • If patient is a cancer survivor, each of the following criteria must apply:
  • +3 more criteria

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 post-operative CT scan or MRI of the abdomen or pelvis
  • Patient, if female and breastfeeding; NOTE: It is not known whether STI571 or its metabolites are excreted in human milk; however, in lactating female rats administered 100 mg/kg, a dose approximately equal to the maximum clinical dose of 800 mg/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; because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, 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 (1 mg orally per day) for prevention of central line-associated deep venous thrombosis is permitted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American College of Surgeons Oncology Group

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • DeMatteo RP, Ballman KV, Antonescu CR, Corless C, Kolesnikova V, von Mehren M, McCarter MD, Norton J, Maki RG, Pisters PW, Demetri GD, Brennan MF, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team for the Alliance for Clinical Trials in Oncology. Long-term results of adjuvant imatinib mesylate in localized, high-risk, primary gastrointestinal stromal tumor: ACOSOG Z9000 (Alliance) intergroup phase 2 trial. Ann Surg. 2013 Sep;258(3):422-9. doi: 10.1097/SLA.0b013e3182a15eb7.

    PMID: 23860199DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Ronald DeMatteo

    American College of Surgeons

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

September 1, 2001

Primary Completion

November 1, 2007

Last Updated

February 20, 2013

Record last verified: 2013-01

Locations

US(1)