Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 19, 2008

Primary Completion Date

August 31, 2010

Study Completion Date

July 6, 2020

Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

Abraxane

100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3

DRUG

Cetuximab

400 mg/m2 IVPB, Day 1, cycle 1

DRUG

Cetuximab

250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3

DRUG

Cisplatin

75 mg/m2 IVPB Day 1, cycles 1, 2 and 3

DRUG

5-FU

750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3

RADIATION

Radiation (Post induction)

Monday-Friday, weeks 1-7

DRUG

Cisplatin

(Post induction) Cisplatin 100 mg/m2 IVPB on radiation day 1, 22 and 42

DRUG

Cetuximab

(Post-induction) Cetuximab (for patients who cannot receive cisplatin) will begin (+/- 3 days) before starting radiation therapy at 400 mg/m2 IVPB. Subsequent doses of cetuximab will be given weekly at 250 mg/m2 IVPB

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT00736944 - Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer | Biotech Hunter | Biotech Hunter