DOXIL for Consolidation Therapy in Ovarian Cancer.

Summary

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).

Timeline

Start

2005-10

Primary completion

2011-10

Completion

2011-10

Publications

• Background Gordon AN, Tonda M, Sun S, Rackoff W; Doxil Study 30-49 Investigators. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol. 2004 Oct;95(1):1-8. doi: 10.1016/j.ygyno.2004.07.011.
• Background Rose PG, Maxson JH, Fusco N, Mossbruger K, Rodriguez M. Liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: a retrospective comparative study of single-agent dosages. Gynecol Oncol. 2001 Aug;82(2):323-8. doi: 10.1006/gyno.2001.6272.

Drugs

Indications