NCT01283334 - A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2014

Conditions

Head and Neck NeoplasmsCancer of the Head and Neck

Interventions

DRUG

Carboplatin

Will be given as a 30 minutes intravenous (IV) infusion on days 1, 8, and 15 of each 28 day cycle. The starting dose of carboplatin will be area under the plasma-concentration time curve (AUC) = 2 mg/ml.min. Appropriate dose reductions will be done for toxicity for subsequent cycles.

DRUG

Cetuximab

Will be given on days 1, 8, 15 and 22 of each 29 day cycle. On week 1, a loading dose of 400 mg/m² will be given. From week 2 onwards, the dose of cetuximab will be 250 mg/m².

DRUG

RAD001

For phase I, dose escalation will be 2.5 mg, 5 mg, 7.5 mg or 10 mg given orally on a daily basis.

Trial Locations (1)

30322

Emory University Winship Cancer Institute, Atlanta