Phase I-II for Patients With Recurrent or Refractory Non-small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT00411593|
Recruitment Status : Withdrawn (Lack of Patient Accrual)
First Posted : December 14, 2006
Last Update Posted : February 8, 2012
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.
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
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Bevacizumab Drug: Bortezomib||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study of Avastin®+ Bortezomib for Patients With Recurrent or Refractory Non-Squamous NSCLC|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
Experimental: Avastin® + Bortezomib
Phase I - 3 * 3 design, enrolling patients to receive Avastin® at a fixed dose of 15 mg/kg every 3 weeks and Bortezomib dosed at 1.6 mg/m2 weekly for 2 weeks out of 3.
Phase II - The MTD for Bortezomib from the weekly schedule that is chosen will be combined with Avastin® to estimate the rate of progression-free survival.
15 g/kg by vein every 3 weeks on day 1 of each cycle.
Other Names:Drug: Bortezomib
Phase I Starting dose: 1.6 mg/m2 by vein on days 1, 8 of each 3 week cycle.
Phase II: MTD from Phase I.
- Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]MTD is defined as the highest dose level in which 6 patients have been treated with 2 patients with dose limiting toxicity (DLT).
- Progression Free Survival [ Time Frame: 1 year ]Patients' progression free survival, 1 year survival and overall survival will be assessed. The survival rate for time to event outcome will be estimated by Kaplan-Meier method. All patients will be followed until death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411593
|Principal Investigator:||Bonnie S. Glisson, MD||M.D. Anderson Cancer Center|