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S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005597
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 3, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

May 2, 2000
January 27, 2003
January 3, 2013
April 2000
October 2005   (Final data collection date for primary outcome measure)
Assess response (confirmed & unconfirmed, complete & partial response) [ Time Frame: 3 years ]
Not Provided
Complete list of historical versions of study NCT00005597 on Archive Site
Toxicities [ Time Frame: 3 years ]
Not Provided
Not Provided
Not Provided
S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
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.


  • 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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumor
Drug: temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
Other Name: NSC-362856
Experimental: Temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
Intervention: Drug: temozolomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2005
October 2005   (Final data collection date for primary outcome measure)


  • 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



  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


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


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


  • Creatinine no greater than 1.5 times ULN


  • 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


Biologic therapy:

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


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

Endocrine therapy:

  • Not specified


  • 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


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


  • At least 30 days since prior investigational drugs
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
S9926 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Mark M. Zalupski, MD University of Michigan Cancer Center
Southwest Oncology Group
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP