Trial intelligence / Profile preview

Carboplatin and Paclitaxel +/- Tirapazamine in Advanced NSCLC

NCT00006484Phase 3

Key facts

Status: Completed
Start: Nov 2000
Countries: 1
Sponsor: SWOG Cancer Research Network
Modality: Small Molecules

Drugs: tirapazamine
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 3, randomised trial of tirapazamine in non-small cell lung cancer (NSCLC) (2 arms), sponsored by SWOG Cancer Research Network. Primary endpoints: Progression-Free Survival and Overall Survival. Started Nov 2000; status: completed.

Design

2 arms

Study design: Randomized

Tirapazamine + Paclitaxel + Carboplatin
Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
Paclitaxel + Carboplatin
Patients receive paclitaxel and carboplatin as in arm I.

Who it enrols

Adults with newly diagnosed or recurrent stage IIIB/IV non-small cell lung cancer, no prior systemic chemotherapy or biologic therapy, Zubrod PS 0-1, adequate organ function, and no brain metastases.

Endpoints

Primary

Progression-Free Survival
Overall Survival

Secondary

Objective Response Rate
Toxic Effects

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