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NCT00028002 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2020-10-26

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Rate of Disease Progression at 2 Years

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outcome · POSTED

Rates of Objective Response (Complete, Partial, and Stable)

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outcome · POSTED

Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)

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outcome · POSTED

FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: Conventional Surgery
    2. Drug: Imatinib Mesylate
    label
    Arm I
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    description
    Undergo surgical resection
    name
    Conventional Surgery
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm I
    description
    Given orally
    name
    Imatinib Mesylate
    other Names
    1. CGP 57148
    2. CGP57148B
    3. Gleevec
    4. Glivec
    5. STI 571
    6. STI-571
    7. STI571
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
63
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf
    measure
    Rate of Disease Progression at 2 Years
    time Frame
    From registration to two years
secondary Outcomes
  1. description
    The percentage of patients who achieved a complete, partial or stable response prior to surgery as assessed by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf.
    measure
    Rates of Objective Response (Complete, Partial, and Stable)
    time Frame
    Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing)
  2. description
    Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.
    measure
    Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)
    time Frame
    Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.
  3. description
    evaluate FDG-PET as a non-invasive functional imaging tool to assess in situ tumor metabolism (as measured by the Standardized Uptake Values of FDG in the tumor) prior to and during the administration of IM. %change in SUVmax \<1 indicate decreased tumor metabolism while values \>1 indicated an increase in tumor metabolism. Metabolic response by 18F-FDG PET was determined in accordance with the criteria of the European Organization for Research and Treatment of Cancer EORTC), with increases or decreases of more than 25% in SUVmax defining progressive metabolic disease (PMD) and partial metabolic response (PMR), respectively, and new lesions defining PMD.
    measure
    FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy
    time Frame
    change from baseline to 1 week post therapy
Full study description
brief Summary
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.
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.
Source references
references
  1. citation
    Van den Abbeele AD, Gatsonis C, de Vries DJ, Melenevsky Y, Szot-Barnes A, Yap JT, Godwin AK, Rink L, Huang M, Blevins M, Sicks J, Eisenberg B, Siegel BA. ACRIN 6665/RTOG 0132 phase II trial of neoadjuvant imatinib mesylate for operable malignant gastrointestinal stromal tumor: monitoring with 18F-FDG PET and correlation with genotype and GLUT4 expression. J Nucl Med. 2012 Apr;53(4):567-74. doi: 10.2967/jnumed.111.094425. Epub 2012 Mar 1.
    pmid
    22381410
    type
    RESULT
  2. 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.
    pmid
    18942073
    type
    RESULT
  3. citation
    Wang D, Zhang Q, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M, Eisenberg BL. Phase II trial of neoadjuvant/adjuvant imatinib mesylate for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumors: long-term follow-up results of Radiation Therapy Oncology Group 0132. Ann Surg Oncol. 2012 Apr;19(4):1074-80. doi: 10.1245/s10434-011-2190-5. Epub 2011 Dec 28.
    pmid
    22203182
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        _372" tabindex="-1">Evidence (phase II studies of neoadjuvant imatinib):</p> <div class="pdq-content-list"><ol id="_373"><li><a href="/clinicaltrials/NCT00028002">RTOG-0132/ACRIN-6665</a> (NCT00028002) was a phase II single-arm study of 52 patients with primary GISTs (n = 30) or operable metastatic GISTs (n = 22). Patie
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        studies of neoadjuvant imatinib):</p> <div class="pdq-content-list"><ol id="_373"><li><a href="/clinicaltrials/NCT00028002">RTOG-0132/ACRIN-6665</a> (NCT00028002) was a phase II single-arm study of 52 patients with primary GISTs (n = 30) or operable metastatic GISTs (n = 22). Patients received preoperative imatinib (600
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      source title
      Gastrointestinal Stromal Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: December 13, 2024
        datetime
        2024-12-13T12:00:00Z
        display
        December 13, 2024

    Preserved source evidence · Not medical advice