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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01221753
First received: September 21, 2010
Last updated: February 20, 2013
Last verified: February 2013

September 21, 2010
February 20, 2013
September 2010
September 2015   (final data collection date for primary outcome measure)
Local-regional Control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To determine the local-regional control at 2 and 5 years in patients with advanced HPV related oropharynx cancer or unknown primary.
Same as current
Complete list of historical versions of study NCT01221753 on ClinicalTrials.gov Archive Site
  • Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To determine progression free survival at 2 and 5 years
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To determine overall survival at 2 and 5 years
  • Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Toxicity rate for each arm
Same as current
Not Provided
Not Provided
 
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Squamous Cell Carcinoma of the Head and Neck
  • Human Papilloma Virus
  • Drug: docetaxel
    Given intravenously on day of each cycle
  • Drug: Cisplatin
    Given intravenously on day 1 of each cycle
  • Drug: 5-fluorouracil
    Given intravenously by pump over 4 days of each cycle
    Other Name: 5-FU
  • Radiation: Intensity modulated radiation therapy
    Once daily 5 days per week for 6-7 weeks
    Other Name: IMRT
  • Drug: carboplatin
    Given intravenously once a week for 6-7 weeks
  • Drug: cetuximab
    Given intravenously once a week for 6-7 weeks
Experimental: One arm Study . TPF induction chemotherapy
Interventions:
  • Drug: docetaxel
  • Drug: Cisplatin
  • Drug: 5-fluorouracil
  • Radiation: Intensity modulated radiation therapy
  • Drug: carboplatin
  • Drug: cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
Not Provided
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01221753
10-038
Yes
Robert I. Haddad, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Robert Haddad, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP