Gastrointestinal Stromal Tumor
Conditions
Keywords
gastrointestinal stromal tumor
Brief 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.
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.
Interventions
DRUGtemozolomide
200 mg/m\^2/day, PO, on Days 1-5 of each 28 day cycle.
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess response (confirmed & unconfirmed, complete & partial response) | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicities | 3 years |
Countries
United States
Outcome results
None listed