DOXIL for Consolidation Therapy in Ovarian Cancer.
The primary objective for this study is to evaluate the development, frequency and severity of hand foot syndrome (HFS) in ovarian cancer subjects treated with Doxil®, as consolidation therapy, on an every two week schedule.
The secondary objective for this study is to assess one-year progression free survival rate (PFS).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Non-randomized Study of DOXIL Consolidation Treatment for Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneal Carcinoma.|
- Development, frequency, and severity of hand-foot syndrome with every two week therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- One-year progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Drug: liposomal doxorubicin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248248
|United States, Georgia|
|Southeastern Gynecologic Oncology|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||Jeffrey F Hines, MD, FACOG||Southeastern Gynecologic Oncology|