Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
HEAD & NECK Cancer
Interventions
OTHER

Cetuximab, IMRT, Albumin-bound paclitaxel (Abraxane®)

"All patients will receive standard treatment with definitive radiation therapy (IMRT, intensity-modulated radiation therapy) administered concurrently with cetuximab (400 mg/m2 intravenous loading dose one week prior to radiation therapy, followed by 250 mg/m2 weekly intravenous infusions). To explore different dose levels of nanoparticle albumin-bound paclitaxel (Abraxane®) given intravenously weekly with the standard regimen of weekly cetuximab + daily radiation therapy.~The total number of planned cetuximab infusions is 8 (loading dose, plus 7 weekly infusions concurrent with radiation therapy). The total number of planned albumin-bound paclitaxel infusions is 7 (all concurrent with radiotherapy). Five dose levels of weekly intravenous (IV) albumin-bound paclitaxel will be explored."

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

Unknown

Memorial Sloan Kettering Cancer Center, Basking Ridge

Memorial Sloan Kettering Cancer Center, Commack

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre

Memoral Sloan Kettering Cancer Center@Phelps, Sleepy Hollow

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

National Comprehensive Cancer Network

NETWORK

lead

Memorial Sloan Kettering Cancer Center

OTHER