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

This study has been terminated.
(Due to slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221753
First Posted: October 15, 2010
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
  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-FU Radiation: IMRT Drug: cetuximab Drug: carboplatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Robert I. Haddad, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 2-Year Local-Regional Control Rate [ Time Frame: Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration. ]
    2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.


Secondary Outcome Measures:
  • 4-y Overall Survival Rate [ Time Frame: Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months). ]
    4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.


Enrollment: 7
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TPF Induction Chemotherapy followed by Chemoradiotherapy
Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
Drug: docetaxel
Other Names:
  • Taxotere
  • Docefrez
Drug: cisplatin
Given intravenously on day 1 of each cycle
Other Name: Platinol-AQ
Drug: 5-FU
Other Name: 5-fluorouracil
Radiation: IMRT
Other Name: Intensity modulated radiation therapy
Drug: cetuximab
Other Name: Erbitux
Drug: carboplatin
Other Name: Paraplatin

Detailed Description:

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 21, 2010
First Posted: October 15, 2010
Results First Submitted: August 15, 2016
Results First Posted: December 6, 2016
Last Update Posted: December 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no data available.

Keywords provided by Robert I. Haddad, MD, Dana-Farber Cancer Institute:
SSCHN
HPV
IMRT

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