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Gastrointestinal Stromal TumorPhase 2NCT00005597

S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

A Phase 2 study testing temozolomide in people with Gastrointestinal Stromal Tumor, run by SWOG Cancer Research Network at 106 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
106 sitesUnited States
Study dates
Apr 2000to Oct 2005
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST)
  • Primary (gastrointestinal or intra-abdominal origin) tumor
  • At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination
  • If lesions within prior radiation port are used as target lesions for response assessment, those lesions must have demonstrated clear progression after completion of radiotherapy
  • No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC (white blood count) at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No medical or psychological conditions that would preclude study participation
  • No major infection requiring systemic antibiotics
  • No uncontrolled bacterial, viral, or fungal infection
  • No other prior malignancy within the past 5 years except:
  • Adequately treated basal cell or squamous cell skin cancer
  • Adequately treated stage I or II cancer in complete remission
  • Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 30 days since prior biologic therapy
  • Prior imatinib mesylate as adjuvant therapy or for metastatic disease allowed

Chemotherapy:

  • No prior chemotherapy for GIST
  • At least 30 days since other prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for GIST
  • No concurrent radiotherapy for GIST
  • Concurrent palliative radiotherapy for painful metastases (encompassing a total portal of no greater than 5 x 5 cm) allowed

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered

Other:

  • At least 30 days since prior investigational drugs

Trial locations and contacts

106 sites in 1 country.

106 sites in 1 country

United States106 sites

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0912

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Barrett Cancer Center

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75216

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80010

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813-2424

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7353

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38103

  • Danville Radiation Therapy Center

    Memphis, Tennessee, 38104

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona, 85012

  • Oregon Cancer Institute

    Portland, Oregon, 97201-3098

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98104

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71130

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

Other trials in United States

About this study

Official title: Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors.

Read the detailed description

OBJECTIVES:

  • Determine the complete and partial response (confirmed and unconfirmed) in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide.
  • Determine the qualitative or quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response (CR) receive 2 additional courses after a confirmed CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 13-27 months.

Being tested
temozolomide
Keywords
gastrointestinal stromal tumor
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.

  • temozolomideDrug

    Also called NSC-362856

    200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.

Study groups in NCT00005597
Study groupRoleWhat they receive
TemozolomideExperimental200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
Receives: Drug: temozolomide

What is being measured

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

  1. Assess response (confirmed & unconfirmed, complete & partial response)

    Measured: 3 years

Secondary outcomes (1)

  1. Toxicities

    Measured: 3 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2000
  3. Primary completionOct 2005
  4. Study completionOct 2005

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005597
Sponsor's protocol ID
CDR0000067710
Other IDs
S9926, U10CA032102
Status last verified
Jan 2013
First submitted
2 May 2000
Last updated
3 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temozolomide in people with Gastrointestinal Stromal Tumor, run by SWOG Cancer Research Network at 106 sites in United States.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess response (confirmed & unconfirmed, complete & partial response) (time frame: 3 years). 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 NCT00005597.

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 3 Jan 2013.

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