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Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00028002
First Posted: January 27, 2003
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eastern Cooperative Oncology Group
American College of Radiology Imaging Network
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec NSC #716051) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase (CD117)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of Disease Progression at 2 Years [ Time Frame: From registration to two years ]
    Kaplan-Meier estimate of disease progression rate. Disease progression is determined by RECIST criteria (Response Evaluation Criteria in Solid Tumours). (RECIST criteria described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf)

  • Rates of Objective Response (Complete, Partial, and Stable) [ Time Frame: Up to 5 years ]
    The response rates along with their 95% confidence intervals will be estimated using a binomial distribution.

  • Incidence of Adverse Events Grade 3 or Greater Graded According to NCI Common Toxicity Criteria (CTC) Version 2.0 (i.e., Major Toxicity) [ Time Frame: Up to 5 years ]
    The major toxicity rates along with their 95% confidence intervals will be estimated using a binomial distribution.

  • Change in Biological Markers of Imatinib Mesylate, Including C-kit and Tyrosine [ Time Frame: to be entered ]

Enrollment: 63
Study Start Date: February 2002
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Procedure: conventional surgery
Undergo surgical resection
Other Name: surgery, conventional

Detailed Description:

OBJECTIVES:

I. Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate.

II. Determine the objective response rate of patients treated with this drug. III. Determine the safety of this drug in these patients.

OUTLINE:

Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed malignant gastrointestinal stromal tumor

    • Potentially resectable primary disease
    • Potentially resectable recurrent disease

      • Local or intra-abdominal/pelvic metastatic disease
  • Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
  • Primary disease must be visceral, intra-abdominal, or pelvic in origin
  • At least 1 unidimensionally measurable lesion

    • At least 5 cm for primary disease
    • At least 2 cm for recurrent disease
  • At least 1 viable core biopsy tumor specimen obtained within 8 weeks before registration
  • Performance status - Zubrod 0-2
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT/AST no greater than 2.5 times ULN
  • No uncontrolled chronic liver disease
  • Creatinine no greater than 1.5 times ULN
  • No uncontrolled chronic renal disease
  • No New York Heart Association class III or IV cardiac disease
  • Must be able to lie still in the PET scanner for approximately 1-2 hours
  • No uncontrollable hyperglycemia
  • No medical or psychological condition that would preclude study participation
  • No severe or uncontrolled medical disease
  • No active uncontrolled infection
  • No known or suspected hypersensitivity to any component of the study drug
  • Any prior malignancy is allowed provided patient remains disease free from that malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • At least 28 days since prior biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • At least 28 days since prior chemotherapy
  • At least 28 days since prior radiotherapy
  • See Disease Characteristics
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028002


Locations
United States, Pennsylvania
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
American College of Radiology Imaging Network
Investigators
Principal Investigator: Burton Eisenberg Radiation Therapy Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028002     History of Changes
Other Study ID Numbers: NCI-2012-02437
NCI-2012-02437 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-RTOG-R0132
RTOG-DEV-1055
ACRIN-6665
CDR0000069111
RTOG-S-0132
RTOG-0132 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0132 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2001
First Posted: January 27, 2003
Results First Submitted: November 29, 2012
Results First Posted: July 10, 2013
Last Update Posted: May 23, 2014
Last Verified: November 2012

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 Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action