drugset / Trial / NCT01467115

Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer

NCT01467115

Phase 2 Completed 1 enrolled Drexel University College of Medicine
NaSingle-groupOpen-labelTreatment

Summary

More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes. Due to these concerns about quality of life after surgery, there has been a lot of interest in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy and biologics has showed promising results. However, questions still remain about the ideal combination treatment regimen. Based on assimilation of data from multiple sources, our study tries to identify the role of a potentially highly effective multi-modality regimen based on induction chemotherapy (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent, Cetuximab, and radiation therapy.

Timeline

Start
2010-03
Primary completion
2014-06
Completion
2014-10-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 35 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous
Background Leucovorin Small molecule 350 mg/m2 Intravenous
Background epoetin alfa Protein / enzyme biologic Subcutaneous
Background filgrastim Protein / enzyme biologic 300 ug/ml Subcutaneous

Indications