drugset / Trial / NCT01221753

Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study

NCT01221753 ↗

Phase 2 Terminated 7 enrolled Dana-Farber Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.

Timeline

Start
2011-07
Primary completion
2012-07
Completion
2017-07

Outcome

Outcome not reported

Stopped (Enrollment): “Due to slow accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 1.5 unknown Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous