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
18 Years
N/A
Both
Squamous Cell Carcinoma of the Head and Neck, Human Papilloma Virus
Trial Information
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
- The initial (induction) chemotherapy part of this study consists of 3 chemotherapy
drugs: docetaxel, cisplatin, and 5-fluorouracil (called TPF). The docetaxel and
cisplatin are given intravenously in the clinic. The 5-fluorouracil is given
intravenously by a pump over 4 days while the participant is at home. This will be
followed by 16 days of no chemotherapy. These drugs are given for a total of 3
cycles, with each cycle lasting 21 days.
- During each cycle of induction chemotherapy the following procedures/tests will be
performed: physical exams; blood tests; fiberoptic exam and quality of life
questionnaires.
- When the participant has completed three cycles of chemotherapy, they will have a CT or
MRI of their neck and a PET scan. The results of these exams will determine how much
radiation they will receive. Only patients with an excellent or complete response to
the initial three cycles of chemotherapy will receive the reduced radiation dose.
- Chemoradiation will consist of chemotherapy given once a week for 6 or 7 weeks along
with radiation. Radiation will be administered once daily 5 days per week for 6 to 7
weeks using a radiation technique called "Intensity Modulated Radiation Therapy" or
IMRT.
- Chemotherapy is given during radiation to make the radiation work better. The
chemotherapy drugs are carboplatin and cetuximab, these drugs are given intravenously
once a week for 6 to 7 weeks.
- During chemoradiation the following procedures/tests will be performed: physical exams;
blood tests and PEG placement. Most patients receiving chemoradiotherapy for head and
neck cancer will develop difficulty swallowing food and drinking liquids during the
course of therapy. For this reason, a gastrostomy tube (PEG) is recommended. A PEG is
a tube that is surgically inserted through the abdominal wall into the stomach that can
be used for nutritional health.
- Eight to ten weeks after the final treatment, we will evaluate the participants
response by CT or MRI of the neck and a PET scan. Participants will be followed for 5
years. During this time they will be seen once a month for three months, and then
every three months for 2 years, then every 6 months for 5 years.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local-regional Control
Outcome Description:
To determine the local-regional control at 2 and 5 years in patients with advanced HPV related oropharynx cancer or unknown primary.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Robert Haddad, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
10-038
NCT ID:
NCT01221753
Start Date:
September 2010
Completion Date:
Related Keywords:
- Squamous Cell Carcinoma of the Head and Neck
- Human Papilloma Virus
- SSCHN
- HPV
- IMRT
- Carcinoma
- Carcinoma, Squamous Cell
- Papilloma
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
