Phase II Trial of Doxorubicin HCl Liposome Injection (Doxil®) in Advanced Stage Cutaneous T-Cell Lymphoma Followed by Bexarotene (Targretin®)
- Determine the progression-free survival of patients with stage IB-IV cutaneous T-cell
lymphoma treated with doxorubicin HCl liposome followed by bexarotene.
- Determine the complete and partial response rate in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive doxorubicin HCl liposome IV over 30-90 minutes once on day 1. Treatment
repeats every 2 weeks for 8 courses. Beginning within 4 weeks after the last dose of
doxorubicin HCl liposome, patients receive oral bexarotene once daily for at least 16 weeks.
Patients who achieve a complete or partial response may continue to receive bexarotene in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1-year progression-free survival
David J. Straus, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Hackensack University Medical Center Cancer Center||Hackensack, New Jersey 07601|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|