NCT00005597
S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
PHASE2
COMPLETED
NCT00005597
INTERVENTIONAL
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.
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
Gastrointestinal Stromal Tumor
- TREATMENT
-
- Type: DRUG
- Name: temozolomide
- Description: 200 mg/m\^2/day, PO, on Days 1-5 of each 28 day cycle.
- Arm Group Labels: Temozolomide
- SWOG Cancer Research Network