S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

January 2, 2013 updated by: Southwest Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Western Regional, Arizona
      • Phoenix, Arizona, United States, 85012
        • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Long Beach, California, United States, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, United States, 90073
        • Veterans Affairs Medical Center - West Los Angeles
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • San Francisco, California, United States, 94143-0128
        • UCSF Comprehensive Cancer Center
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, United States, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • MBCCOP - Howard University Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • CCOP - Atlanta Regional
      • Fort Gordon, Georgia, United States, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
      • Honolulu, Hawaii, United States, 96813-2424
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, United States, 60153-5500
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7353
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
      • Lexington, Kentucky, United States, 40502-2236
        • Veterans Affairs Medical Center - Lexington
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, United States, 71130
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Jamaica Plain, Massachusetts, United States, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, United States, 48109-0912
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
      • Southfield, Michigan, United States, 48075-9975
        • Providence Hospital - Southfield
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • CCOP - Duluth
    • Mississippi
      • Biloxi, Mississippi, United States, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Health Sciences Center
      • Springfield, Missouri, United States, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • Albany, New York, United States, 12208
        • Veterans Affairs Medical Center - Albany
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, United States, 45267-0501
        • Barrett Cancer Center
      • Cleveland, Ohio, United States, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Veterans Affairs Medical Center - Oklahoma City
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, United States, 97201-3098
        • Oregon Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee Cancer Institute
      • Memphis, Tennessee, United States, 38104
        • Danville Radiation Therapy Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, United States, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Dallas, Texas, United States, 75216
        • Veterans Affairs Medical Center - Dallas
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, United States, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Veterans Affairs Medical Center - Houston
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • MBCCOP - Massey Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Tacoma, Washington, United States, 98431-5000
        • Madigan Army Medical Center
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
Drug: temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
Other Names:
  • NSC-362856

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess response (confirmed & unconfirmed, complete & partial response)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicities
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Mark M. Zalupski, MD, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067710
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S9926 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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