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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck, Human Papilloma Virus

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
cisplatin
5-FU
IMRT
cetuximab
carboplatin
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring SSCHN, HPV, IMRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TPF Induction Chemotherapy followed by Chemoradiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

2-Year Local-Regional Control Rate
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
4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.

Full Information

First Posted
September 21, 2010
Last Updated
November 1, 2017
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01221753
Brief Title
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to slow accrual
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck, Human Papilloma Virus
Keywords
SSCHN, HPV, IMRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPF Induction Chemotherapy followed by Chemoradiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere, Docefrez
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Platinol-AQ
Intervention Description
Given intravenously on day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
5-fluorouracil
Intervention Type
Radiation
Intervention Name(s)
IMRT
Other Intervention Name(s)
Intensity modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin
Primary Outcome Measure Information:
Title
2-Year Local-Regional Control Rate
Description
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.
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.
Secondary Outcome Measure Information:
Title
4-y Overall Survival Rate
Description
4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Haddad, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no data available.

Learn more about this trial

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

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