A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma
- Estimate the response rate in patients with recurrent or stage III or IV primary
endometrial carcinoma treated with doxorubicin hydrochloride liposome and carboplatin.
- Determine progression-free survival of patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin
IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 months and then every 3
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response (complete and partial)
Every 28 days
Shashikant B. Lele, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|