Trial intelligence / Profile preview

Induction Carbo/Gem then Concurrent Pac/Vin/RT in NSCLC

NCT00004093Phase 2

Key facts

Status: Terminated
Start: Aug 1999
Primary completion: Feb 2002
Countries: 1
Sponsor: Northwestern University
Modality: Small Molecules

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

Overview

Phase 2, open-label, single-arm trial of vinorelbine in non-small cell lung cancer (NSCLC), sponsored by Northwestern University. Primary endpoints: Maximum Tolerated Dose and Radiologic Response Rate. Started Aug 1999; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Dose Escalation Arm
Induction Carbo/Gem -> Concurrent Pac/Vin/RT (Vinorelbine dose escalated) -> Surgery -> Adjuvant Carbo/Gem

Who it enrols

Patients with stage IIIA or IIIB NSCLC (N2/N3), ECOG 0-2, adequate organ function, and no prior chemotherapy or thoracic radiation.

Endpoints

Primary

Maximum Tolerated DoseAfter each cycle of therapy
Radiologic Response RateAfter every 2 cycles of study therapy

Secondary

Pathologic Response RateAt time of resection
Time to ProgressionUp to 1 month post-treatment
Overall SurvivalUp to 1 month post-treatment
Quality of LifeThroughout study

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