A Randomized, Double-Blind, Multicenter, Phase II Study To Assess The Safety, Tolerability, And Efficacy Of ZD6474 In Combination With Docetaxel (TAXOTERE) In Subjects With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure Of Prior Platinum-Based Chemotherapy
- Compare the efficacy of ZD6474 and docetaxel vs docetaxel and placebo, in terms of
progression-free survival, in patients with locally advanced or metastatic non-small
cell lung cancer refractory to platinum-based chemotherapy.
- Compare the tolerability and safety of these regimens, in terms of incidence and nature
of adverse effects and electrocardiogram changes, in these patients.
- Compare the objective response rate and duration of response of patients treated with
- Compare the pharmacokinetics of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
- Compare objective tumor response and progression-free survival with the biological
assessment of these regimens in these patients.
- Compare quality of life, lung cancer symptoms, and performance status of patients
treated with these regimens.
OUTLINE: This is a multicenter, two-phase study comprising an open-label phase followed by a
double-blind, randomized phase.
- Open-label phase: Patients receive docetaxel IV over 1 hour on day 1 and oral ZD6474
once daily beginning on day 2. Treatment repeats every 21 days for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity.
- Randomized phase: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1 and oral ZD6474 once
daily beginning on day 1.
- Arm II: Patients receive docetaxel as in arm I and ZD6474 as in arm I but at a
- Arm III: Patients receive docetaxel as in arm I and oral placebo once daily
beginning on day 1.
In all arms, courses repeat every 21 days in the absence of disease progression or
Quality of life is assessed at baseline, after the first 4 courses, and then after every
other course thereafter.
Patients are followed at 30 days and then every 6 weeks thereafter.
PROJECTED ACCRUAL: A total of 129 patients (9 patients for the open-label phase, 120
patients [40 per treatment arm] for the randomized phase) will be accrued for this study
within approximately 8 months (3 months for the open-label phase, 5 months for the
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Diane Prager, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|