A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy
- Determine the objective tumor response rate and duration of response in patients with
progressive locally advanced or metastatic non-small cell lung cancer treated with
soblidotin as second-line therapy after receiving prior platinum-based chemotherapy.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival time and 12-month survival rate of patients treated with
- Determine the quantitative and qualitative toxic effects of this drug in these
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity. Plasma sampling for
pharmacokinetics is done on day 1 of course 1.
Patients are followed for survival every 3 months after discontinuing study treatment.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.
Masking: Open Label, Primary Purpose: Treatment
Peter Cheverton, MD, ChB, MMED, RadT
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Medical Oncology and Hematology, P.C.||Hamden, Connecticut 06518|