Breast Cancer Clinical Trial
Official title:
Continuous Temozolomide (SCH 52365) in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer, Phase II
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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