ZD6474 and Docetaxel in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. ZD6474 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of ZD6474 combined with docetaxel in treating patients who have locally advanced or metastatic non-small cell lung cancer that is refractory to platinum-based chemotherapy.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||November 2002|
|Study Completion Date:||December 2007|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
- 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 these regimens.
- 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 higher dose.
- 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 unacceptable toxicity.
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 randomized phase).
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Diane Prager, MD||Jonsson Comprehensive Cancer Center|