NCT00660218 - A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

December 31, 2016

Study Completion Date

April 30, 2017

Conditions

Carcinoma, Squamous Cell

Interventions

DRUG

paclitaxel poliglumex

Phase I: 40 mg/m2 IV weekly in Cohort 1 (first 3 subjects), escalating in increments of 10 mg/m2 for Cohorts 2 through 5 (3 subjects each) until the maximum tolerated dose (up to 80 mg/m2 IV weekly) is established; Phase II: MTD mg/m2 IV weekly as established in Phase I (24 additional subjects)

BIOLOGICAL

cetuximab

400 mg/m2 IV loading dose one week prior to starting other study treatments, then 250 mg/m2 IV weekly on same day as paclitaxel poliglumex

RADIATION

radiation therapy (IMRT or 3D-CRT)

radiation therapy to the head and neck, consisting of 33 daily fractions of 2.12 Gy for a total of 69.96 Gy, to begin the same day as paclitaxel poliglumex

Trial Locations (1)

13210

SUNY Upstate Medical University, Syracuse