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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 4
- Locations
- 21
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Velcade Alone
Velcade
Intervention: bortezomib (Drug)
Velcade plus Docetaxel
Velcade plus Docetaxel
Intervention: bortezomib (Drug)
Velcade plus Docetaxel
Velcade plus Docetaxel
Intervention: docetaxel (Drug)