NCT00291707 - Trial of Cetuximab and Pemetrexed With Radiation in Head and Neck Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

January 31, 2009

Conditions

Head and Neck Cancer

Interventions

DRUG

Cetuximab

The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. The infusion rate of cetuximab must never exceed 5 mL/min.

DRUG

Pemetrexed

• Pemetrexed 350-500 mg/m2 IV over 10 minutes (see dose escalation design. Dose will be decreased to 200 mg/m2, if the first dose level of 350 mg/m2 is not tolerable) on days 1 and 22, (and 43 if \>6000 cGy to be delivered)

PROCEDURE

radiation therapy

• Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1. Radiation will be given M-F for 6-7 consecutives weeks

Trial Locations (1)

15232

University of Pittsburgh, Pittsburgh