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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:
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01221753
First received: September 21, 2010
Last updated: October 13, 2016
Last verified: October 2016

September 21, 2010
October 13, 2016
July 2011
July 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01221753 on ClinicalTrials.gov Archive Site
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). ] [ Designated as safety issue: No ]
4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.
  • 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
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.

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

Interventional
Phase 2
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
    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
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.
Interventions:
  • Drug: docetaxel
  • Drug: cisplatin
  • Drug: 5-FU
  • Radiation: IMRT
  • Drug: cetuximab
  • Drug: carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
July 2017
July 2012   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01221753
10-038
Yes
No
There is no data available.
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
October 2016

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