A Phase II, Open Label Study Of T138067-Sodium In A Second-Line Setting In Non-Small-Cell Lung Cancer Patients With Locally Advanced Or Metastatic Disease Who Have Failed First-Line Therapy With a Taxane
OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced
or metastatic non-small cell lung cancer who have failed first-line therapy with a taxane
when treated with T138067 sodium. II. Determine the qualitative and quantitative toxic
effects of this drug in these patients. III. Determine the number of patients who progress
when treated with this drug. IV. Determine the duration of response, time to disease
progression, and median survival of patients treated with this drug. V. Correlate the toxic
effects of this drug with peak plasma levels in this patient population.
OUTLINE: This is a multicenter study. Patients receive T138067 sodium IV over 3 hours on
days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months after study completion.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 9 months.
Primary Purpose: Treatment
United States: Federal Government
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|