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Taxoprexin Plus Carboplatin Treatment for Advanced Lung Cancer

NCT00243867 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2025-08-01

Study results available
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Summary

The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

Conditions

Interventions

DRUG

Taxoprexin

Administered by intravenous infusion over 1 hour infusion

DRUG

Carboplatin

Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate (GFR) + 25).

DRUG

Paclitaxel

Administered by intravenous infusion over 3 hour infusion

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark A Falone, MD · American Regent, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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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 NCT00243867 on ClinicalTrials.gov