Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Cancer
Interventions
DRUG

Docetaxel

Docetaxel 75 mg/m\^2 IV over 1 hour, day 1

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.

DRUG

Cetuximab

Cetuximab dose will be 250 mg/m\^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).

PROCEDURE

Radiation Therapy

Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies\>6 MV may be utilized when appropriate to boost target localized centrally.

Trial Locations (1)

15232

University of Pittsburgh Medical Center, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

University of Pittsburgh

OTHER