Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer|
|Study Start Date:||May 2003|
|Study Completion Date:||July 2004|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
Active Comparator: Velcade Alone
Experimental: Velcade plus Docetaxel
Velcade plus Docetaxel
|Drug: bortezomib Drug: docetaxel|
- Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel.
- Compare time to progression in patients treated with these regimens.
- Compare the overall and 1-year survival of patients treated with these regimens.
- Compare the safety and tolerability of these regimens in these patients.
- Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR.
Quality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment.
Patients are followed at 30 days and then every 3 months for survival.
PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.