search
Back to results

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

Primary Purpose

Gastrointestinal Stromal Tumor

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
imatinib mesylate
conventional surgery
Sponsored by
Peking University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor focused on measuring Gastrointestinal Stromal Tumor, Imatinib mesylate, Perioperative therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University School of Oncology

Outcomes

Primary Outcome Measures

Rate of disease recurrence at 2 years

Secondary Outcome Measures

Rates of objective response (complete, partial, and stable)
Determine the safety and tolerability of this drug in these patients.

Full Information

First Posted
December 27, 2010
Last Updated
February 2, 2015
Sponsor
Peking University
search

1. Study Identification

Unique Protocol Identification Number
NCT01267695
Brief Title
Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Official Title
Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Open-label trial in patients with locally advanced GISTs admitted to Department of Surgery, Beijing Cancer Hospital and Institute between April 2010 and May 2013 was carried out prospectively. Patients were planned to be treated with imatinib for duration of 6 months followed by surgical resection. Postoperative imatinib was planned to be administrated for 1.5 years. The primary end point was recurrent free survival (RFS) at 2 years; the secondary end points included objective response rate (ORR), surgical outcomes and drug safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor
Keywords
Gastrointestinal Stromal Tumor, Imatinib mesylate, Perioperative therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
Gleevec, STI-571, NSC #716051
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
All the patients should receive elective surgery with R0 resection.
Primary Outcome Measure Information:
Title
Rate of disease recurrence at 2 years
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Rates of objective response (complete, partial, and stable)
Time Frame
2 years
Title
Determine the safety and tolerability of this drug in these patients.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Peking University School of Oncology
City
Beijing
ZIP/Postal Code
100142
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
18942073
Citation
Eisenberg BL, Harris J, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M. Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol. 2009 Jan 1;99(1):42-7. doi: 10.1002/jso.21160.
Results Reference
background
PubMed Identifier
20160360
Citation
Seshadri RA, Rajendranath R. Neoadjuvant imatinib in locally advanced gastrointestinal stromal tumors. J Cancer Res Ther. 2009 Oct-Dec;5(4):267-71. doi: 10.4103/0973-1482.59905.
Results Reference
background
PubMed Identifier
19944196
Citation
Saied GM, Kensarah AM. Six months neoadjuvant imatinib improves resectability potential of gastric stromal tumors in Egyptian patients. Int J Surg. 2010;8(2):105-8. doi: 10.1016/j.ijsu.2009.09.016. Epub 2009 Nov 24.
Results Reference
background
PubMed Identifier
21040362
Citation
Machlenkin S, Pinsk I, Tulchinsky H, Ziv Y, Sayfan J, Duek D, Rabau M, Walfisch S. The effect of neoadjuvant Imatinib therapy on outcome and survival after rectal gastrointestinal stromal tumour. Colorectal Dis. 2011 Oct;13(10):1110-5. doi: 10.1111/j.1463-1318.2010.02442.x.
Results Reference
background
Links:
URL
http://www.uptodate.com/patients/content/topic.do?topicKey=~1ahlhQH65OZROGa
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs