A Double Blind Randomized Trial of Cediranib Versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
- To compare overall survival of patients with stage IIIB-IV non-small cell lung cancer
treated with cediranib vs placebo administered in combination with paclitaxel and
- To compare the progression-free survival of patients treated with these regimens.
- To compare the objective response rates in patients treated with these regimens.
- To estimate time to response and response duration in patients treated with these
- To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and
hemoptysis, in patients treated with these regimens.
- To compare the pharmacokinetics of paclitaxel between the two arms in a subset of
- To compare the quality of life of patients treated with these regimens.
- To determine the incremental cost effectiveness and cost utility ratios for these
- To correlate the expression of tissue markers (at diagnosis) with outcomes and response
in an exploratory fashion OUTLINE: This is a multicenter study. Patients are stratified
by gender, center, disease stage (IIIB vs IV), weight loss (< 5% vs 5-10% vs unknown),
and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 2
- Arm I: Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3
hours and carboplatin IV over 30 minutes on day 1.
- Arm II: Patients receive oral placebo once daily on days 1-21 and paclitaxel and
carboplatin as in arm I.
Treatment in both arms repeats every 21 days for 4 to 6 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and periodically
After completion of study therapy, patients are followed every 12 weeks.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
at every visit throughout trial
Scott A. Laurie, MD, FRCPC
Ottawa Regional Cancer Centre
Canada: Health Canada