A Phase 2 interventional study of temozolomide in Gastrointestinal Stromal Tumor, sponsored by SWOG Cancer Research Network. Completed at 106 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-03.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
345 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 60 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 253 interventional studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors studies →SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST)
At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No other prior malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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.
Also known as: NSC-362856
Assess response (confirmed & unconfirmed, complete & partial response)
Time frame: 3 years
Toxicities
Time frame: 3 years
Showing the first 100 of 106 sites.
The record gives a start of Apr 2000, a primary completion of Oct 2005 and a completion of Oct 2005. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Temozolomide
Gastrointestinal Stromal Tumors →
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