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

Stopped early · Phase 2

Conditions studied: Squamous Cell Carcinoma of the Head and Neck, Human Papilloma Virus

In brief

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.

Key facts

Study ID

NCT01221753

Run by

Dana-Farber Cancer Institute

People needed

7

Starts

2011-07-01

Expected to finish

2017-07-01

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC.
• Stage 3 or 4 disease without evidence of distant metastases
• At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria
• 18 years of age or older
• No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry
• ECOG Performance Status of 0 or 1
• No active alcohol addiction
• Adequate bone marrow, hepatic and renal function as defined in the protocol
• Women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment

You may not qualify if…

• Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after
• Previous or current malignancies at other sites
• Symptomatic peripheral neuropathy of grade 2 or greater
• Symptomatic altered hearing greater than grade 2
• Other serious illnesses or medical conditions
• Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
• Concurrent treatment with any other anticancer therapy
• Participation in an investigational trial within 30 days of study entry

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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