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

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
American College of Radiology Imaging Network
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00028002
First received: December 7, 2001
Last updated: May 7, 2014
Last verified: November 2012

December 7, 2001
May 7, 2014
February 2002
January 2009   (final data collection date for primary outcome measure)
  • Rate of Disease Progression at 2 Years [ Time Frame: From registration to two years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00028002 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
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)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
  • Drug: imatinib mesylate
    Given orally
    Other Names:
    • CGP 57148
    • Gleevec
    • Glivec
  • Procedure: conventional surgery
    Undergo surgical resection
    Other Name: surgery, conventional
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.
Interventions:
  • Drug: imatinib mesylate
  • Procedure: conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00028002
NCI-2012-02437, NCI-2012-02437, ECOG-RTOG-R0132, RTOG-DEV-1055, ACRIN-6665, CDR0000069111, RTOG-S-0132, RTOG-0132, RTOG-0132, U10CA021661
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
  • American College of Radiology Imaging Network
Principal Investigator: Burton Eisenberg Radiation Therapy Oncology Group
National Cancer Institute (NCI)
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP