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
NCIC Clinical Trials Group
OBJECTIVES: Primary * Compare the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer treated with paclitaxel and carboplatin in combination with either cediranib maleate or a placebo. * Determine the pharmacogenomics and pharmacodynamic aspects of these regimens in these patients. (Phase II) * Compare the overall survival of patients treated with these regimens. (Phase III) Secondary * Compare objective tumor response rates in patients treated with these regimens. * Determine the time to response and response duration in patients treated with these regimens. (Phase III) * Determine the nature, severity, and frequency of the toxic effects of these regimens, including hemorrhage and hemoptysis, in these patients. * Correlate the expression of tissue markers (at diagnosis) with outcomes and response in patients treated with these regimens. (Phase III) * Compare quality of life of patients treated with these regimens. (Phase III) OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, participating center, disease stage (IIIB vs IV), weight loss (≥ 5% vs \< 5%), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral cediranib maleate once daily in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment with paclitaxel and carboplatin repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel and carboplatin as in arm I. Quality of life is assessed at baseline, before each treatment course, after completion of study treatment, and every 3 months thereafter. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
