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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.
First Received: December 7, 2001   Last Updated: September 15, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborators: National Cancer Institute (NCI)
American College of Radiology Imaging Network
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028002
  Purpose

RATIONALE: 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.

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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:
  • Biological effects of imatinib mesylate [ Designated as safety issue: No ]
  • Rate of disease recurrence at 2 years [ Designated as safety issue: No ]
  • Rates of objective response (complete, partial, and stable) [ Designated as safety issue: No ]
  • Major toxicity (i.e., grade ≥ 3) [ Designated as safety issue: Yes ]
  • Correlation of glucose transported expression and positron emission tomography (PET) interpretations [ Designated as safety issue: No ]
  • Tumor changes observed on PET and correlation with size changes observed on conventional cross-sectional imaging [ Designated as safety issue: No ]
  • Diagnostic accuracy of PET to predict disease recurrence [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: February 2002
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate.
  • Determine the objective response rate of patients treated with this drug.
  • 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.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 2 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant gastrointestinal stromal tumor

    • Potentially resectable primary disease OR
    • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN
  • No uncontrolled chronic renal disease

Cardiovascular:

  • No New York Heart Association class III or IV cardiac disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 28 days since prior biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

  • At least 28 days since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 28 days since prior radiotherapy

Surgery:

  • See Disease Characteristics

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028002

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Radiation Therapy Oncology Group
American College of Radiology Imaging Network
Eastern Cooperative Oncology Group
Investigators
Study Chair: Burton L. Eisenberg, MD Norris Cotton Cancer Center
Study Chair: Annick D. Van den Abbeele, MD Dana-Farber Cancer Institute
Study Chair: Margaret von Mehren, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069111, RTOG-S-0132, ACRIN-6665, RTOG-DEV-1055, ECOG-RTOG-R0132
Study First Received: December 7, 2001
Last Updated: September 15, 2009
ClinicalTrials.gov Identifier: NCT00028002     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on November 09, 2009