Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | July 2011 |
| End Date: | July 2017 |
A Phase II Study of Docetaxel/Cisplatin/5-Fluorouracil (TPF) Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Using a Modified Radiation Dose in Patients With Newly Diagnosed HPV Positive, Locally Advanced Squamous Cell Carcinoma of the Oropharynx
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.
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.
OBJECTIVES:
Primary
To determine rate of local-regional control at 2 years
Secondary
To determine Progression Free Survival at 2 and 5 years
To determine Overall Survival at 2 and 5 years
To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years
Primary
To determine rate of local-regional control at 2 years
Secondary
To determine Progression Free Survival at 2 and 5 years
To determine Overall Survival at 2 and 5 years
To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years
Inclusion Criteria
- 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
Exclusion Criteria
- 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
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