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
  Purpose

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.


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Human Papilloma Virus
Drug: docetaxel
Drug: Cisplatin
Drug: 5-fluorouracil
Radiation: Intensity modulated radiation therapy
Drug: carboplatin
Drug: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 7
Study Start Date: September 2010
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One arm Study . TPF induction chemotherapy 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

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221753

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Robert Haddad, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Robert I. Haddad, MD, Medical Oncology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01221753     History of Changes
Other Study ID Numbers: 10-038
Study First Received: September 21, 2010
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
SSCHN
HPV
IMRT

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Papilloma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cetuximab
Cisplatin
Fluorouracil
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 14, 2014