The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma.
Because repeated dosing of temozolomide correlates with an improved response, which may be due to progressive depletion of the enzyme AT, our hope is that a daily oral schedule will be the most active schedule of this agent. In phase I studies doses below 85 mg/m2/day continuously have been well-tolerated. We plan to begin dosing at 75 mg/m2/day for 6 weeks out of an 8 week cycle and to escalate to 85 and 100 mg/m2/day in patients who have no grade 3/4 toxicity. The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma. To do this we will assess the response rate, time to progression, and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
Response rate
Time frame: <= 78 months
Time to disease progression
Time frame: <= 78 months
Survival
Time frame: <= 78 months
To determine the toxicity of the regimen.
Time frame: <= 78 months
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