Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2010 by Peking University
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01267695
First received: December 27, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. This phase II trial is studying the effectiveness of perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal stromal tumor.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Rate of disease recurrence at 2 years [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of objective response (complete, partial, and stable) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determine the safety and tolerability of this drug in these patients. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: imatinib mesylate
    Patients receive oral imatinib mesylate once daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients with disease progression or unacceptable toxicity are considered for immediate surgical resection. Within 2-6 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for one and a half years.
    Other Names:
    • Gleevec
    • STI-571
    • NSC #716051
    Procedure: conventional surgery
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • DISEASE CHARACTERISTICS:

    • Histologically confirmed gastrointestinal stromal tumor

      • Locally advanced disease: tumour size 〉5 cm and mitotic count 〉5/HPF; tumour size 〉10 cm; mitotic count 〉10/HPF
      • Potentially resectable disease: Multivisceral resection may be necessary to get sufficient margins
    • Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
    • At least 1 site of measurable disease
    • No known brain metastases
  • PATIENT CHARACTERISTICS:

Age:18 and over Performance status:ECOG 0-3 Life expectancy:Not specified

  • Platelet count > 100,000/mm3
  • Absolute neutrophil count > 1,500/mm3 Hepatic
  • AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Bilirubin < 1.5 times ULN
  • No chronic active hepatitis
  • No cirrhosis
  • No other chronic liver disease Renal
  • Creatinine < 1.5 times ULN
  • No chronic renal disease Cardiovascular
  • No New York Heart Association class III-IV cardiac disease
  • No congestive heart failure
  • No myocardial infarction within the past 6 months Immunology
  • No active uncontrolled infection
  • No known HIV positivity Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
  • Must be medically fit to undergo surgery
  • No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
  • No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
  • No uncontrolled diabetes
  • No other severe or uncontrolled medical disease
  • No significant history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

  • No concurrent anticancer biologic agents
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
  • No concurrent anticancer chemotherapy
  • At least 28 days since prior radiotherapy
  • More than 2 weeks since prior major surgery except tumor biopsy Other
  • At least 28 days since prior investigational drugs
  • At least 28 days since prior imatinib mesylate
  • No concurrent therapeutic doses of warfarin
  • Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267695

Contacts
Contact: Jiafu Ji, master 86-10-88196048 dr.jijiafu@gmail.com

Locations
China
Peking University School of Oncology Recruiting
Beijing, China, 100142
Principal Investigator: Jiafu Ji, master         
Sponsors and Collaborators
Peking University
  More Information

Additional Information:
Publications:
Responsible Party: Peking University ( Jiafu Ji )
ClinicalTrials.gov Identifier: NCT01267695     History of Changes
Other Study ID Numbers: WJP-320.6700.09010
Study First Received: December 27, 2010
Last Updated: December 27, 2010
Health Authority: China: Ethics Committee

Keywords provided by Peking University:
Gastrointestinal Stromal Tumor
Imatinib mesylate
Perioperative therapy

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014