Phase I-II for Patients With Recurrent or Refractory Non-small Cell Lung Cancer (NSCLC)

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00411593
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    15 g/kg by vein every 3 weeks on day 1 of each cycle.
  • Bortezomib — DRUG
    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.

Study Details

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

Key Dates

First listed
Dec 14, 2006
Start date
Nov 30, 2006
Status verified
Feb 2012
Primary completion
May 31, 2007
Completion
May 31, 2007

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]

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