Trial intelligence / Profile preview

Gemcitabine and Doxorubicin in Recurrent Head and Neck Cancer

NCT00509665Phase 2

Key facts

Status: Completed
Start: Jun 2005
Primary completion: May 2011
Countries: 1
Sponsor: Medical University of South Carolina
Modality: Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes

Drugs: gemcitabinepegylated liposomal doxorubicin
Conditions: head and neck cancer (HNC)

Overview

Phase 2, open-label, single-arm trial of gemcitabine and pegylated liposomal doxorubicin in head and neck cancer (HNC), sponsored by Medical University of South Carolina. Primary endpoint: Response Rate up to 8 months. Started Jun 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Gemcitabine+doxorubicin
Gemcitabine and Doxorubicin combination chemotherapy

Who it enrols

Patients with histologically confirmed recurrent or progressive head and neck cancer who have received prior platinum-based chemotherapy, with adequate organ function and performance status.

Endpoints

Primary

Response Rateup to 8 months

Secondary

Duration of Responseup to 8 months
Progression-free Survivalup to 8 months
Overall Survivaluntil death
Number of Patients Who Had Greater Than Grade 2 Toxicityup to 6 months
Correlation of Cytotoxicity With Cell-cycle Arrest and Apoptosisup to 6 months

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