A Phase II/III Double Blind Randomized Trial of AZD2171 Versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
- 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)
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Glenwood D. Goss, MD, BCh, FCP, FRCPC
Ottawa Regional Cancer Centre
Canada: Health Canada