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Gastrointestinal Stromal TumorPhase 3NCT00009906

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

A Phase 3 study testing Imatinib Mesylate in people with Gastrointestinal Stromal Tumor, run by National Cancer Institute (NCI) at 144 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
Imatinib Mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
748 participants
Where
144 sitesin 3 countries
Study dates
Dec 2000to Nov 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

144 sites in 3 countries.

144 sites in 3 countries

United States132 sites

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • University of Michigan University Hospital

    Ann Arbor, Michigan, 48109

  • Our Lady Bellefonte Hospital

    Ashland, Kentucky, 41101

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Atlanta Regional CCOP

    Atlanta, Georgia, 30342

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Central Vermont Medical Center

    Barre, Vermont, 05641

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Northwestern University

    Chicago, Illinois, 60611

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Columbus CCOP

    Columbus, Ohio, 43215

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023-1291

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Central Illinois CCOP

    Decatur, Illinois, 62526

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Alexian Brothers Medical and Cancer Center

    Elk Grove Village, Illinois, 60007

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Hackensack University Medical CCOP

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates-Hampton

    Hampton, Virginia, 23666

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Sky Lakes Medical Center - Cancer Treatment Center

    Klamath Falls, Oregon, 97601

  • Hematology Oncology Associates

    Lake Worth, Florida, 33461

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Long Beach Community Hospital

    Long Beach, California, 90804

  • University of Southern California/Norris Cancer Center

    Los Angeles, California, 90033

  • University of California at Los Angeles Health System

    Los Angeles, California, 90095

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Middlesex Hospital

    Middletown, Connecticut, 06457

  • Winthrop University Hospital

    Mineola, New York, 11501

  • University of Minnesota Medical Center-Fairview

    Minneapolis, Minnesota, 55455

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • Beth Israel Medical Center

    New York, New York, 10003

  • New York University Langone Medical Center

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Mid-Illinois Hematology Oncology Associates

    Normal, Illinois, 61761

  • Sutter Cancer Research Consortium

    Novato, California, 94945

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Advocate Lutheran General Hospital.

    Park Ridge, Illinois, 60068

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Aria Health-Torresdale Campus

    Philadelphia, Pennsylvania, 19114

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Western Regional CCOP

    Phoenix, Arizona, 85006

  • Western Oncology Research Consortium

    Portland, Oregon, 97213

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Kansas City CCOP

    Prairie Village, Kansas, 66208

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Highlands Oncology Group-Rogers

    Rogers, Arkansas, 72758

  • Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Saint Joseph's Health Center

    Saint Charles, Missouri, 63301

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Salem Hospital

    Salem, Oregon, 97301

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of California San Diego

    San Diego, California, 92103

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Santa Rosa Memorial Hospital

    Sana Rosa, California, 95405

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Group Health

    Seattle, Washington, 98109

  • Upstate Carolina CCOP

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield

    Springfield, Missouri, 65804

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Stanford University Hospitals and Clinics

    Stanford, California, 94305

  • Northwest CCOP

    Tacoma, Washington, 98405

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • Stormont-Vail Regional Health Center

    Topeka, Kansas, 66604

  • University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • MedStar Oncology Network

    Washington D.C., District of Columbia, 20010

  • Southeast Cancer Control Consortium CCOP

    Winston-Salem, North Carolina, 27104

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada10 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hamilton and District Urology Association McMaster Institute

    Hamilton, Ontario, L8N 4A6

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Ottawa Health Research Institute-General Division

    Ottawa, Ontario, K1H 1C4

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Puerto Rico2 sites

  • San Juan Veterans Affairs Medical Center

    San Juan, 00921-3201

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: Phase III Randomized, Intergroup Trial Assessing the Clinical Activity Of STI-571 at Two Dose Levels in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the Kit Receptor Tyrosine Kinase (CD117)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Imatinib Mesylate
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib MesylateDrug

    Given orally

Study groups in NCT00009906
Study groupRoleWhat they receive
Arm I (imatinib mesylate)ExperimentalPatients receive oral imatinib mesylate once daily.
Receives: Drug: Imatinib Mesylate
Arm II (imatinib mesylate)ExperimentalPatients receive oral imatinib mesylate twice daily.
Receives: Drug: Imatinib Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Measured: Up to 3 years

  2. Progression-free survival

    Measured: From date of registration to date of first observation of progressive disease or death due to any cause, assessed up to 3 years

  3. 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

    Measured: Up to 3 year after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2004 (estimated)
  2. Study startDec 2000
  3. Primary completionMay 2007
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
748 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00009906
Sponsor's protocol ID
NCI-2012-02372
Other IDs
NCI-2012-02372, S0033, INT-S0033, CDR0000068422, CAN-NCIC-S0033, CLB-80004, SWOG-S0033, E-S0033
Status last verified
Jun 2014
First submitted
2 Feb 2001
Last updated
23 Dec 2014
Results posted
No

Publications

  • 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.

    PubMed 28196207

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Imatinib Mesylate in people with Gastrointestinal Stromal Tumor, run by National Cancer Institute (NCI) at 144 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00009906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.

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