Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
CTI BioPharma
OBJECTIVES: * Compare the efficacy of polyglutamate paclitaxel (CT-2103) vs docetaxel as second-line therapy, in terms of duration of overall survival, in patients with progressive non-small cell lung cancer. * Compare the safety and toxicity of these regimens in these patients. * Compare the disease control (stable disease maintained for at least 12 weeks, partial response, or complete response) and progression-free survival of patients treated with these regimens. * Compare the improvement in lung cancer symptoms in patients treated with these regimens. * Compare the frequency of grade 3 and 4 neurotoxicity, edema, alopecia, and side effects related to corticosteroids in patients treated with these regimens. * Determine the percentage of patients who receive at least 4 courses of study treatment. * Compare the response rate in patients with measurable disease treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to stage (IV vs other), performance status (0 or 1 vs 2), start of front-line chemotherapy from randomization (less than 16 weeks vs at least 16 weeks), gender, and prior taxane therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive polyglutamate paclitaxel (CT-2103) IV over 10 minutes on day 1. * Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 840 patients (420 per treatment arm) will be accrued for this study within 18 months.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
