A Phase I Trial of Abraxane, Cisplatin and 5-Fluorouracil Along With Chemoradiotherapy in Advanced Head and Neck Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Head and Neck Cancer
Interventions
DRUG

ABI-007

Dose escalation beginning with ABI-007 75 mg/m2 day 1 + day 8, Cisplatin 100 mg/m2 day 1, 5-Fluorouracil (5-FU) 1000 mg/m2/d continuous infusion x 96 hours on day 1-4, for 3 weeks x 3 cycles. Followed by Concurrent weekly Carboplatin (AUC 1.5) with radiotherapy for 7 weeks. Carboplatin should be given on Monday or Tuesday of each week, if possible.

Trial Locations (1)

M5G 3M9

Princess Margaret Hospital, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

University Health Network, Toronto

OTHER