Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Eastern Cooperative Oncology Group
With
OBJECTIVES: * Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease or bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum closed to accrual as of 7/16/04). * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only) (measurable disease stratum closed to accrual as of 7/16/04). Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 180 patients (90 per stratum \[with or without prior therapy\]) will be accrued for this study within 6 months (based on prior accrual, the bone metastases only group \[specifically patients who have received 1 prior therapy\] is the only stratum open for accrual).
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
