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Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy

NCT00424840 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-02-01

Study results available
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Summary

A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this regimen. This will form the basis for future studies comparing this combination to what is now considered standard regimen for first line therapy in patients with NSCLC, carboplatin, paclitaxel and bevacizumab.

Conditions

Interventions

DRUG

Bortezomib 1.3 mg/m2

Level I (every 21 day cycle, D8), 1.3 mg/m2: Day 1: bevacizumab 15 mg/kg ,carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.3 mg/m2 Day 8 : bortezomib 1.3 mg/m2 Level II (every 21 day cycle): Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.6 mg/m2 Day 8 : bortezomib 1.6 mg/m2 Level III(every 21 day cycle): Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.8 mg/m2 Day 8 : bortezomib 1.8 mg/m2

DRUG

Bortezomib 1.6 mg/m2

Level II (every 21 day cycle, D8), 1.6 mg/m2

DRUG

Bortezomib 1.8 mg/m2

Level III (every 21 day cycle, D8) 1.8 mg/m2

DRUG

Carboplatin AUC 6

Carboplatin AUC6

DRUG

Bevacizumab

Bevacizumab 15 mg/kg

DRUG

Taxotere

Taxotere 70 + G-CSF

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • William Walsh, MD · University of MassachusettsMedical School

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2014-03-31
Completion
2014-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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 NCT00424840 on ClinicalTrials.gov