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Gastrointestinal Stromal TumorPhase 2NCT00025246

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

A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Gastrointestinal Stromal Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
imatinib mesylate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteUnited States
Study dates
Sep 2001to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • American College of Surgeons Oncology Group

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: A Phase II Study of Adjuvant STI571 (Gleevec TM) Therapy in Patients Following Completely Resected High-risk Primary GastroIntestinal Stromal Tumor (GIST)

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. To ascertain whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with STI571 have prolonged survival compared to historical controls.

SECONDARY OBJECTIVES:

  1. To determine the 2 and 5-year prevalence of recurrence in patients treated with adjuvant STI571 following complete resection of high-risk primary GIST.

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

III. To assess the toxicity of oral STI571 therapy when used in the adjuvant setting.

OUTLINE:

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.

After completion of study treatment, patients are followed periodically for up to 10 years.

Being tested
imatinib mesylate, laboratory biomarker analysis
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called CGP 57148, Gleevec, Glivec

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00025246
Study groupRoleWhat they receive
Treatment (imatinib mesylate)ExperimentalPatients 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.
Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Prevalence of recurrence free survival

    Marginal point and two-sided 95% (pointwise) confidence bands, based on Kaplan-Meier estimator will be produced.

    Measured: 2 years

  2. Prevalence of recurrence

    Marginal point and two-sided 95% (pointwise) confidence bands, based on Kaplan-Meier estimator will be produced.

    Measured: 5 years

  3. Overall survival

    Marginal point and two-sided 95% (pointwise) confidence bands, based on Kaplan-Meier estimator will be produced.

    Measured: Up to 5 years

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

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2001
  3. Primary completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025246
Sponsor's protocol ID
NCI-2012-03079
Other IDs
ACOSOG-Z9000, U10CA076001, CDR0000068942
Status last verified
Jan 2013
First submitted
11 Oct 2001
Last updated
20 Feb 2013
Results posted
No

Publications

  • 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.

    PubMed 23860199

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Gastrointestinal Stromal Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination whether patients with completely resected high-risk primary GIST who undergo adjuvant treatment with imatinib mesylate have prolonged survival compared to historical controls (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00025246, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.

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