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

Phase 2
18 Years
Not Enrolling
Gastrointestinal Stromal Tumor

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Trial Information

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


- Determine the complete and partial response (confirmed and unconfirmed) in patients
with unresectable or metastatic gastrointestinal stromal tumors treated with

- Determine the qualitative or quantitative toxic effects of this regimen in these

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

Inclusion Criteria


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Mark M. Zalupski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2000

Completion Date:

October 2005

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • gastrointestinal stromal tumor
  • Gastrointestinal Stromal Tumors



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
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City of Hope Comprehensive Cancer Center Duarte, California  91010
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Danville Radiation Therapy Center Memphis, Tennessee  38104
University of Tennessee Cancer Institute Memphis, Tennessee  38103
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Barrett Cancer Center Cincinnati, Ohio  45267-0502
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Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060