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

NCT ID: NCT01221753

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2017-07-31

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

Conditions

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

Keywords

SSCHN; HPV; IMRT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

Given intravenously on day 1 of each cycle

5-FU

Intervention Type: DRUG

IMRT

Intervention Type: RADIATION

cetuximab

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

Interventions

docetaxel

Intervention Type: DRUG

cisplatin

Given intravenously on day 1 of each cycle

Intervention Type: DRUG

5-FU

Intervention Type: DRUG

IMRT

Intervention Type: RADIATION

cetuximab

Intervention Type: DRUG

carboplatin

Intervention Type: DRUG

Other Intervention Names

Taxotere; Docefrez; Platinol-AQ; 5-fluorouracil; Intensity modulated radiation therapy; Erbitux; Paraplatin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Robert I. Haddad, MD

Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Haddad, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10-038

Identifier Type: -

Identifier Source: org_study_id