NCT01794845

Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

Detailed description

The investigator's approach is based on the following reasons: * Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest. * LDFRT will render enhanced bax activation mediated mode of cell death. * Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death. * The toxicity profile is expected to be minimal. Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.

Conditions

• Squamous Cell Carcinoma
• Head and Neck Cancer
• Recurrent Disease

Interventions

Type	Name	Description
DRUG	Erbitux	Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
DRUG	Taxotere	Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
RADIATION	Low Dose Fractionated Radiation Therapy	Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.

Timeline

• Start date: 2013-06-03
• Primary completion: 2016-06-07
• Completion: 2016-06-07
• First posted: 2013-02-20
• Last updated: 2017-05-11
• Results posted: 2017-05-11

Locations

1 site across 1 country: United States