MedTrace Logo

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

NCT00411593 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2012-02-08

No results posted yet for this study

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

Conditions

Interventions

DRUG

Bevacizumab

15 g/kg by vein every 3 weeks on day 1 of each cycle.

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.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Bonnie S. Glisson, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-05-31
Completion
2007-05-31

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00411593 on ClinicalTrials.gov