Torisel in Addition to Standard Chemotherapy With Radiation for Advanced Head and Neck Cancer

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 8, 2011

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Head and Neck Cancer
Interventions
DRUG

Temsirolimus

All patients will receive temsirolimus. The dose of temsirolimus in this study will range from 15-25 mg depending on the dose level. Temsirolimus will be infused over a 30-60 minute period once a week for the duration of radiation therapy.

DRUG

Cetuximab

"All patients will receive cetuximab. An initial loading dose of cetuximab 400 mg/m2, intravenously over 120 minutes at least 4 days before radiation therapy but no more than 7 days before the start of radiation therapy.~Thereafter, cetuximab will be infused at 250 mg/m2 dose over 60 minutes weekly for the duration of radiation therapy."

DRUG

Cisplatin

All patients in Cohort A will receive cisplatin. The dose will be 20 mg/m2 or 30 mg/m2 depending upon the dose level.

DEVICE

Radiation Therapy

Patients will be treated on a linear accelerator fitted with multi-leaf collimators with 1.6-2.3 Gy fractions delivered daily 5 days per week over 4-7 weeks to a cumulative dose of 66 Gy. A variance of +/- 10% in this nominal prescription dose is allowable and will depend on the extent of residual disease, at the discretion of the attending radiation oncologist.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

NCT01326468 - Torisel in Addition to Standard Chemotherapy With Radiation for Advanced Head and Neck Cancer | Biotech Hunter | Biotech Hunter