Clinical Trial: S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
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 Summary:
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.
Sponsor: Southwest Oncology Group
Current Primary Outcome: Assess response (confirmed & unconfirmed, complete & partial response) [ Time Frame: 3 years ]
Original Primary Outcome:
Current Secondary Outcome: Toxicities [ Time Frame: 3 years ]
Original Secondary Outcome:
Information By: Southwest Oncology Group
Dates:
Date Received: May 2, 2000
Date Started: April 2000
Date Completion:
Last Updated: January 2, 2013
Last Verified: January 2013
