Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields
- Determine the therapeutic activity of lurtotecan liposome in patients with metastatic
or loco-regionally recurrent squamous cell carcinoma of the head and neck.
- Determine the objective response, duration of response, and time to progression in
patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Determine the possible pharmacokinetic/pharmacodynamic relationship of this drug in
OUTLINE: This is a multicenter study. Patients are stratified according to presence of a
target lesion in a previously irradiated field (within vs outside).
Patients receive lurtotecan liposome IV over 30 minutes on days 1 and 8. Treatment repeats
every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 38-72 patients (19-36 per stratum) will be accrued for this
Primary Purpose: Treatment
Florence Duffaud, MD
CHU de la Timone
United States: Federal Government