Skip to content
Triangle logo TriangleGet started
← Study library

NCT00009906 · CITED IN SOURCE DOCUMENTS

Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

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

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2014-12-23

Randomized phase III trial to compare the effectiveness of two different doses of STI571 in treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571 may interfere with the growth of tumor cells and may be an effective treatment for cancer. It is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal tumors.

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.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) which is distantly metastatic or unresectable; tumors must meet BOTH of the following criteria: * The primary must be of visceral or intra-abdominal origin * All patients must have immunohistochemical documentation of KIT (CD117) expression by tumor documented by DAKO antibody staining for suggested methodology) Material must be submitted to the CALGB Pathology Coordinating Center for pathology review; it is strongly recommended that snap-frozen tissue biopsy and sera be stored for future submission whenever possible * Patient must have measurable or non-measurable disease by conventional scan imaging (CT or MRI) or physical examination; tests used to assess disease must have been performed within 28 days prior to registration; if a target lesion has been previously embolized or irradiated, there must be objective evidence of progression to be considered for response assessment * Patient must have an identified team (including a medical oncologist and a surgeon) to provide care * Patient must not have known brain metastasis * Patient must have a Zubrod performance status of 0 - 3 * Patient must have resolution of transient toxicities from any prior therapy to =\< grade 1 (NCI-CTC version 2.0) * The patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to registration; patients must not have had a major surgery within 14 days prior to registration * If day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day * In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday two weeks later would be considered day 14; this allows for efficient patient scheduling without exceeding the guidelines * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base * Patients on lower dose arm (Arm 1) will be allowed to increase the daily dose of STI-571 in the case of disease progression; if there is questionable disease progression, the treating investigator should contact the primary Study Coordinator, Dr. George Demetri at 617/632-3985 to review progression information and discuss treatment options
healthy Volunteers
false
minimum Age
15 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive oral imatinib mesylate once daily.
    intervention Names
    1. Drug: Imatinib Mesylate
    label
    Arm I (imatinib mesylate)
    type
    EXPERIMENTAL
  2. description
    Patients receive oral imatinib mesylate twice daily.
    intervention Names
    1. Drug: Imatinib Mesylate
    label
    Arm II (imatinib mesylate)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I (imatinib mesylate)
    2. Arm II (imatinib mesylate)
    description
    Given orally
    name
    Imatinib Mesylate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
748
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival (OS)
    time Frame
    Up to 3 years
  2. measure
    Progression-free survival
    time Frame
    From date of registration to date of first observation of progressive disease or death due to any cause, assessed up to 3 years
  3. measure
    Toxicity defined as any grade 3 or greater organ toxicity, or any grade 4 or greater hematological toxicity as assessed by CTCAE version 2.0
    time Frame
    Up to 3 year after completion of treatment
Full study description
brief Summary
Randomized phase III trial to compare the effectiveness of two different doses of STI571 in treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571 may interfere with the growth of tumor cells and may be an effective treatment for cancer. It is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal tumors.
detailed Description
PRIMARY OBJECTIVES: I. Compare the overall and progression-free survival of patients with CD117-expressing metastatic or unresectable gastrointestinal stromal tumor treated with two different doses of imatinib mesylate. II. Compare the confirmed, unconfirmed, complete, and partial response rates in patients treated with these regimens. III. Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral imatinib mesylate once daily. Arm II: Patients receive oral imatinib mesylate twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients in arm I with progressive disease may cross over to arm II and receive treatment in the absence of further disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 24 months.
Source references
references
  1. citation
    Heinrich MC, Rankin C, Blanke CD, Demetri GD, Borden EC, Ryan CW, von Mehren M, Blackstein ME, Priebat DA, Tap WD, Maki RG, Corless CL, Fletcher JA, Owzar K, Crowley JJ, Benjamin RS, Baker LH. Correlation of Long-term Results of Imatinib in Advanced Gastrointestinal Stromal Tumors With Next-Generation Sequencing Results: Analysis of Phase 3 SWOG Intergroup Trial S0033. JAMA Oncol. 2017 Jul 1;3(7):944-952. doi: 10.1001/jamaoncol.2016.6728.
    pmid
    28196207
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-6180b18e76bf23fa2b66
      requested nct id
      NCT00009906
      primary nct id
      NCT00009906
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      1821570f1f1edcd2e91dd6cdd3682304d1cf58d35597a8795d79a4d1d893d9bb
      payload sha256
      382fb84efdd928ac81fd16dc8a2fe1f8bfb5836ad6da2f827adf2f59348657d4
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-6180b18e76bf23fa2b66
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00009906
      occurrences
      1. context exact
        three patients had stable disease.[<a href="#cit/section_5.3">3</a>] </li><li>In the phase III SWOG Cancer Research Network intergroup <a href="/clinicaltrials/NCT00009906">S0033 (NCT00009906)</a> trial, 20 tumors from patients presumed to have wild-type disease were resequenced.[<a href="#cit/section_5.8">8</a>] <div class="pdq
        end
        53203
        exact text
        NCT00009906
        start
        53192
      2. context exact
        table disease.[<a href="#cit/section_5.3">3</a>] </li><li>In the phase III SWOG Cancer Research Network intergroup <a href="/clinicaltrials/NCT00009906">S0033 (NCT00009906)</a> trial, 20 tumors from patients presumed to have wild-type disease were resequenced.[<a href="#cit/section_5.8">8</a>] <div class="pdq-content-list"><ul i
        end
        53223
        exact text
        NCT00009906
        start
        53212
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/6ee02d513e1f50072e.html
      source file sha256
      1821570f1f1edcd2e91dd6cdd3682304d1cf58d35597a8795d79a4d1d893d9bb
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:22:19.155967+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      bb8012dd8318ecbf92e3697d6870b0a79e5a9a7c4b95416de7d0b6a70b9dfca7
      source title
      Childhood Gastrointestinal Stromal Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: September 5, 2024
        datetime
        2024-09-05T12:00:00Z
        display
        September 5, 2024

    Preserved source evidence · Not medical advice