NCT00005597

S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	temozolomide	200 mg/m\^2/day, PO, on Days 1-5 of each 28 day cycle.

Timeline

• Start date: 2000-04-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2003-01-27
• Last updated: 2013-01-03

Locations

106 sites across 1 country: United States