A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Effects of Zometa® in Combination With Taxotere®/Carboplatin in Patients With Stage IIIB/IV Unresectable Non-Small Cell Lung Cancer
- Compare the proportion of patients without disease progression at 6 months among
patients with unresectable stage IIIB or stage IV non-small cell lung cancer treated
with docetaxel and carboplatin with vs without zoledronate.
- Compare time to disease progression in patients treated with these regimens.
- Compare response rate in patients treated with these regimens.
- Compare time to progression in bone in patients treated with these regimens.
- Compare 1-year overall survival in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour followed by zoledronate IV over 15
minutes and carboplatin IV over 15 minutes on day 1.
- Arm II: Patients receive docetaxel IV over 1 hour followed by carboplatin IV over 15
minutes on day 1.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. After completion of 6 courses of therapy, patients in
arm I who have responding or stable disease are then re-randomized to 1 of 2 arms.
- Arm I: Patients receive zoledronate IV over 15 minutes monthly for 12 months from the
date of the first chemotherapy dose.
- Arm II: Patients receive no further treatment. Patients are followed every 1 or 3
months for 12 months from the date of the first chemotherapy dose.
PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with no disease progression after 6 courses
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|