NCT01009346 - RAD001 in Combination With Cetuximab and Cisplatin in Recurrent and Metastatic SCCHN | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions

Head and Neck Cancer

Interventions

DRUG

RAD001

"Dose Level -1 2.5mg/day~Dose Level 1 5mg/day\*~Dose Level 2 10mg/day~MTD RAD001"

DRUG

Cetuximab

250mg/m2/week

DRUG

Cisplatin

40mg/m2 Day 1, 8 every 28 days

DRUG

Carboplatin

"Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:~Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance."

Trial Locations (1)

21231

Johns Hopkins University, Baltimore