RAD001 (Everolimus) + Docetaxel + Cisplatin as Induction Chemotherapy in Patients With Local-Regional Advanced Head and Neck Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
HEAD & NECK Cancer
Interventions
DRUG

RAD001 + docetaxel + cisplatin

Patients will receive daily RAD001 (everolimus, per dose escalation scheme) plus concurrent docetaxel (75 mg/m2 intravenously every 3 weeks) + cisplatin (75 mg/m2 intravenously every 3 weeks). Pegfilgrastim (6 mg/subcutaneously) will be administered on day 2 of each cycle. Patients will be followed for toxicity for 30 days after the last dose of RAD001. Patients should undergo re-staging imaging studies within 2 - 6 weeks after the final treatment with cisplatin/docetaxel. After the completion of induction chemotherapy and the 30-day observation period after treatment, patients are removed from the study.

Trial Locations (5)

10065

Memorial Sloan-Kettering Cancer Center, New York

10591

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow

11725

Memorial Sloan-Kettering Cancer Center at Commack, Commack

07939

Memorial Sloan-Kettering Cancer Center at Basking Ridge, Basking Ridge

Unknown

Memorial Sloan-Kettering at Mercy Medical Center, Rockville Centre

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER