Phase I-II for Patients With Recurrent or Refractory Non-small Cell Lung Cancer (NSCLC)
Status:
Withdrawn
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
Summary
Primary Objective
The primary objective of this phase I-II study is to evaluate:
- Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with
bevacizumab given every 3 weeks.
- Phase II: Using the MTD established in phase I, assess efficacy of the combination as
indicated by progression-free survival.
Secondary Objectives
The secondary objectives of this study are to evaluate:
- Response rates and duration of response
- 1 year survival
- Overall survival
- Qualitative and quantitative toxicity
- Circulating endothelial cells (CECs) prior to treatment, prior to cycle 2, and/or at the
time of progression