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Gastrointestinal Stromal TumorsPhase 2NCT00290485

Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

A Phase 2 study testing Imatinib mesylate in people with Gastrointestinal Stromal Tumors, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to demonstrate that the use of Gleevec in initially non-resectable gastrointestinal stromal tumors can lead to allow complete resection in 20% of cases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumors
What is being tested?
Imatinib mesylate
How many people
50 participants
Where
1 siteCanada
Study dates
Aug 2005to not given
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • GIST patient considered initially non-resectable as defined by one of the following:
  • when the surgical team considers that the risk of incomplete resection (R1 or R2) of a GIST is higher than 20%
  • when the resection of a GIST necessitates a highly morbid procedure
  • when a GIST is attached to 3 or more major intra-abdominal structures or to a major intra-abdominal blood vessel
  • when GIST is considered at very high risk of recurrence. This is the case when it is a recurrence or when the tumor is in very close contact with a structure that cannot be resected by surgery or when the patient has metastasis.
  • Outpatient is 18 years old or more
Show all 12Show fewer
  • ECOG performance status 0, 1 or 2
  • Immunohistochemical confirmation of KIT overexpression must exist at the study entry
  • Measurable disease on CT-Scan or MRI (ultrasound and/or operative finding are not acceptable) and response to RECIST criteria
  • Have a life expectancy of at least 6 months
  • Be willing and able to comply with the protocol (and surgery if required) for the duration of the study
  • Give written informed consent prior to study-specific screening procedure, with the understanding that the patient has the right to withdraw from the study at any time without prejudice

Who cannot join

  • received Imatinib in the past
  • received a full course of radiotherapy within 3 months of inclusion in the study. A short course of radiotherapy to control bleeding is allowed.
  • received systemic chemotherapy within 4 weeks of inclusion in the study
  • received steroids for less than 4 weeks of inclusion in the study
  • pregnant or lactating women
  • women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
Show all 19Show fewer
  • sexually active males or females (of childbearing potential) unwilling to practice contraception during the study
  • history of other malignancy within the past 5 years, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  • clinical or other evidence of CNS metastases
  • myocardial infarction within the last 3 months
  • any medical condition that contraindicates potential surgery
  • lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication
  • any serious uncontrolled concomitant disease
  • any of the following laboratory values:
  • absolute neutrophil count < 1.5 E+09/L
  • platelet count < 80000 E+09/L
  • AST or ALT higher than 2 X normal
  • major surgery within 4 weeks prior to start of study treatment, or lack of complete recovery from effects of major surgery
  • patients with known or suspected hypersensitivity to one of the Gleevec components.

Trial locations and contacts

1 site in 1 country.

Pierre Dubé, MD contact

(514) 252-3822

pierredube@videotron.qc.ca

Canada1 site, 1 recruiting

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, h1t 2m4

    Pierre Dubé, MD, (514) 252-3822, pierredube@videotron.qc.ca

    Pierre Dubé, MD

    Recruiting

Other trials in Canada

About this study

Official title: A Phase II Study on Preoperative Administration of Gleevec in Patients With Initially Non-Resectable Gastrointestinal Stromal Tumor

The aim of this study is to demonstrate that the use of Gleevec in initially non-resectable gastrointestinal stromal tumors can lead to allow complete resection in 20% of cases.

Read the detailed description

Gastrointestinal stromal tumor (GIST) is a specific, immunohistochemically KIT+ mesenchymal neoplasm of the gastrointestinal tract. The identification of KIT+ tumor has become more important after introduction of target treatment with KIT tyrosine kinase inhibitor Imatinib mesylate (Gleevec). Despite this progress, GIST patients presenting a tumor larger than 5 cm have a 10 year survival between 10% and 30%. Indeed, the risk of microscopic spreading of the tumor during surgery is very high since intra-abdominal organs are in close relation to each others. To improve survival, it seemed logical to use preoperative Gleevec to reduce tumor size and improve efficacy of the surgical procedure.

Being tested
Imatinib mesylate
Keywords
non-resectable tumor, high-risk tumor, metastasis, Response Evaluation Criteria in Solid Tumors (RECIST), Gleevec, Imatinib mesylate
Medical subject headings
Gastrointestinal Stromal Tumors, Neoplasm Metastasis

What participants receive

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

  • Imatinib mesylateDrug

What is being measured

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

  1. Patient response rate according to RECIST criteria

Secondary outcomes (8)

  1. Clinical response to treatment

  2. Radiological response to treatment

  3. Pathological response to treatment

  4. Compare clinical with pathological response

  5. Evaluate the impact of Gleevec on surgical morbidity

  6. Evaluate disease-free survival

  7. Evaluate overall survival

  8. Evaluate whether the response rate can predict survival

Timeline

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

  1. First posted13 Feb 2006 (estimated)
  2. Study startAug 2005

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290485
Sponsor's protocol ID
Q-CTG-01-V7.0-A1
Status last verified
Apr 2006
First submitted
9 Feb 2006
Last updated
7 Apr 2006
Results posted
No

Publications

  • Kitamura Y, Hirota S, Nishida T. Gastrointestinal stromal tumors (GIST): a model for molecule-based diagnosis and treatment of solid tumors. Cancer Sci. 2003 Apr;94(4):315-20. doi: 10.1111/j.1349-7006.2003.tb01439.x.

    PubMed 12824897

  • Judson I. Gastrointestinal stromal tumours (GIST): biology and treatment. Ann Oncol. 2002;13 Suppl 4:287-9. doi: 10.1093/annonc/mdf672. No abstract available.

    PubMed 12401703

  • Greenson JK. Gastrointestinal stromal tumors and other mesenchymal lesions of the gut. Mod Pathol. 2003 Apr;16(4):366-75. doi: 10.1097/01.MP.0000062860.60390.C7.

    PubMed 12692202

  • Rosai J. GIST: an update. Int J Surg Pathol. 2003 Jul;11(3):177-86. doi: 10.1177/106689690301100304. No abstract available.

    PubMed 12894349

  • Bono P, Krause A, von Mehren M, Heinrich MC, Blanke CD, Dimitrijevic S, Demetri GD, Joensuu H. Serum KIT and KIT ligand levels in patients with gastrointestinal stromal tumors treated with imatinib. Blood. 2004 Apr 15;103(8):2929-35. doi: 10.1182/blood-2003-10-3443. Epub 2004 Jan 8.

    PubMed 15070666

  • Schirru A, Cavaliere D, Cosce U, Scarimbolo M, Griseri G, Caristo I, Bianchi M, Ingravaglieri E, Aiello D, Venturino E. [Surgical treatment of gastrointestinal stromal tumors: personal cases]. Tumori. 2003 Jul-Aug;89(4 Suppl):141-2. Italian.

    PubMed 12903574

  • Liberati G, Lucchetta MC, Petraccia L, Nocchi S, Rosentzwig R, De Matteis A, Grassi M. [Meta-analytical study of gastrointestinal stromal tumors (GIST)]. Clin Ter. 2003 Mar-Apr;154(2):85-91. Italian.

    PubMed 12856366

  • Kanda T, Ohashi M, Makino S, Kaneko K, Matsuki A, Nakagawa S, Hatakeyama K. A successful case of oral molecularly targeted therapy with imatinib for peritoneal metastasis of a gastrointestinal stromal tumor. Int J Clin Oncol. 2003 Jun;8(3):180-3. doi: 10.1007/s10147-003-0321-0.

    PubMed 12851843

  • Miettinen M, Lasota J. Gastrointestinal stromal tumors (GISTs): definition, occurrence, pathology, differential diagnosis and molecular genetics. Pol J Pathol. 2003;54(1):3-24.

    PubMed 12817876

  • DeMatteo RP. The GIST of targeted cancer therapy: a tumor (gastrointestinal stromal tumor), a mutated gene (c-kit), and a molecular inhibitor (STI571). Ann Surg Oncol. 2002 Nov;9(9):831-9. doi: 10.1007/BF02557518.

    PubMed 12417503

  • Tuveson DA, Willis NA, Jacks T, Griffin JD, Singer S, Fletcher CD, Fletcher JA, Demetri GD. STI571 inactivation of the gastrointestinal stromal tumor c-KIT oncoprotein: biological and clinical implications. Oncogene. 2001 Aug 16;20(36):5054-8. doi: 10.1038/sj.onc.1204704.

    PubMed 11526490

  • Blanke CD, Eisenberg BL, Heinrich MC. Gastrointestinal stromal tumors. Curr Treat Options Oncol. 2001 Dec;2(6):485-91. doi: 10.1007/s11864-001-0070-0.

    PubMed 12057094

  • Yan H, Marchettini P, Acherman YI, Gething SA, Brun E, Sugarbaker PH. Prognostic assessment of gastrointestinal stromal tumor. Am J Clin Oncol. 2003 Jun;26(3):221-8. doi: 10.1097/01.COC.0000018296.45892.CE.

    PubMed 12796588

  • Noguchi T, Sato T, Takeno S, Uchida Y, Kashima K, Yokoyama S, Muller W. Biological analysis of gastrointestinal stromal tumors. Oncol Rep. 2002 Nov-Dec;9(6):1277-82.

    PubMed 12375034

  • Kovac D, Petrovecki M, Jasic M, Dobi-Babic R, Ivanis N, Rubinic M, Krizanac S, Jonjic N, Rizzardi C, Melato M. Prognostic factors of gastrointestinal stromal tumors. Anticancer Res. 2002 May-Jun;22(3):1913-7.

    PubMed 12168893

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib mesylate in people with Gastrointestinal Stromal Tumors, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

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 12 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 7 Apr 2006. 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 Canada. 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?

Results are not available in the source record.

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

Contact Pierre Dubé, MD ((514) 252-3822, pierredube@videotron.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient response rate according to RECIST criteria. 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 NCT00290485, which also lists 26 linked publications.

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 7 Apr 2006.

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