Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

NCT00290485 | Unknown Phase 2

• 1 other identifier: Q-CTG-01-V7.0-A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

non-resectable tumor; high-risk tumor; metastasis; Response Evaluation Criteria in Solid Tumors (RECIST); Gleevec; Imatinib mesylate

Outcome Measures

Primary Outcomes (1)

• Patient response rate according to RECIST criteria

Secondary Outcomes (8)

• Clinical response to treatment

• Radiological response to treatment

• Pathological response to treatment

• Compare clinical with pathological response

• Evaluate the impact of Gleevec on surgical morbidity

Interventions

Imatinib mesylate DRUG

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• received Imatinib in the past
• 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.
• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Hippocrate Research & Development: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, h1t 2m4, Canada

RECRUITING

Related Publications (26)

• 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.

  PMID: 12824897 BACKGROUND

• 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.

  PMID: 12401703 BACKGROUND

• 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.

  PMID: 12692202 BACKGROUND

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

  PMID: 12894349 BACKGROUND

• 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.

  PMID: 15070666 BACKGROUND

• 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.

  PMID: 12903574 BACKGROUND

• 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.

  PMID: 12856366 BACKGROUND

• 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.

  PMID: 12851843 BACKGROUND

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

  PMID: 12817876 BACKGROUND

• 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.

  PMID: 12417503 BACKGROUND

• 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.

  PMID: 11526490 BACKGROUND

• 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.

  PMID: 12057094 BACKGROUND

• 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.

  PMID: 12796588 BACKGROUND

• 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.

  PMID: 12375034 BACKGROUND

• 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.

  PMID: 12168893 BACKGROUND

• Connolly EM, Gaffney E, Reynolds JV. Gastrointestinal stromal tumours. Br J Surg. 2003 Oct;90(10):1178-86. doi: 10.1002/bjs.4352.

  PMID: 14515284 BACKGROUND

• Crosby JA, Catton CN, Davis A, Couture J, O'Sullivan B, Kandel R, Swallow CJ. Malignant gastrointestinal stromal tumors of the small intestine: a review of 50 cases from a prospective database. Ann Surg Oncol. 2001 Jan-Feb;8(1):50-9. doi: 10.1007/s10434-001-0050-4.

  PMID: 11206225 BACKGROUND

• Joensuu H. Treatment of inoperable gastrointestinal stromal tumor (GIST) with Imatinib (Glivec, Gleevec). Med Klin (Munich). 2002 Jan 15;97 Suppl 1:28-30.

  PMID: 11831069 BACKGROUND

• Rajput A, Kraybill WG. Clinical trials and soft tissue sarcomas. Surg Oncol Clin N Am. 2003 Apr;12(2):485-97. doi: 10.1016/s1055-3207(03)00002-4.

  PMID: 12916465 BACKGROUND

• Patel SR. Systemic therapy for advanced soft-tissue sarcomas. Curr Oncol Rep. 2002 Jul;4(4):299-304. doi: 10.1007/s11912-002-0005-3.

  PMID: 12044239 BACKGROUND

• Eisenberg BL. Imatinib mesylate: a molecularly targeted therapy for gastrointestinal stromal tumors. Oncology (Williston Park). 2003 Nov;17(11):1615-20; discussion 1620, 1623, 1626 passim.

  PMID: 14682111 BACKGROUND

• Rossi CR, Mocellin S, Mencarelli R, Foletto M, Pilati P, Nitti D, Lise M. Gastrointestinal stromal tumors: from a surgical to a molecular approach. Int J Cancer. 2003 Nov 1;107(2):171-6. doi: 10.1002/ijc.11374.

  PMID: 12949790 BACKGROUND

• Radford IR. Imatinib. Novartis. Curr Opin Investig Drugs. 2002 Mar;3(3):492-9.

  PMID: 12054102 BACKGROUND

• Frolov A, Chahwan S, Ochs M, Arnoletti JP, Pan ZZ, Favorova O, Fletcher J, von Mehren M, Eisenberg B, Godwin AK. Response markers and the molecular mechanisms of action of Gleevec in gastrointestinal stromal tumors. Mol Cancer Ther. 2003 Aug;2(8):699-709.

  PMID: 12939459 BACKGROUND

• Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80. doi: 10.1056/NEJMoa020461.

  PMID: 12181401 BACKGROUND

• Bumming P, Andersson J, Meis-Kindblom JM, Klingenstierna H, Engstrom K, Stierner U, Wangberg B, Jansson S, Ahlman H, Kindblom LG, Nilsson B. Neoadjuvant, adjuvant and palliative treatment of gastrointestinal stromal tumours (GIST) with imatinib: a centre-based study of 17 patients. Br J Cancer. 2003 Aug 4;89(3):460-4. doi: 10.1038/sj.bjc.6600965.

  PMID: 12888812 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Pierre Dubé, MD

  Maisonneuve-Rosemont Hospital

  STUDY CHAIR

Central Study Contacts

Pierre Dubé, MD

CONTACT

(514) 252-3822; pierredube@videotron.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: August 1, 2005
• Last Updated: April 7, 2006

Record last verified: 2006-04

Locations

CA (1)