Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

NCT00721513 | Completed Phase 2 Results DMC FDA Drug

• 5 other identifiers: IRB00005784P30CA012197CCCWFU-60108CCCWFU-IRB- IRB00005784SANOFI-AVENTIS-CCCWFU-60108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with cetuximab and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and fluorouracil together with cetuximab and radiation therapy works in treating patients with locally advanced head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  up to 2 years

Secondary Outcomes (8)

• Objective Response Rate

  up to 2 years

• Best Overall Response Rate

  up to 2 years

• Overall Survival

  up to 2 years

• Number of Participants With Distant Metastasis

  up to 2 years

• Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G)

  Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years

Study Arms (1)

TPFChemotherapy + Concomitant Cetuximab & RT

EXPERIMENTAL

Taxotere/Cisplatinum/5-Fluorouracil (TPF) Chemotherapy Followed by Concomitant Cetuximab \& Radiation Therapy

Biological: cetuximab; Drug: cisplatin; Drug: docetaxel; Drug: fluorouracil; Procedure: computed tomography; Procedure: positron emission tomography; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

Interventions

cetuximab BIOLOGICAL

TPFChemotherapy + Concomitant Cetuximab & RT

cisplatin DRUG

TPFChemotherapy + Concomitant Cetuximab & RT

docetaxel DRUG

TPFChemotherapy + Concomitant Cetuximab & RT

fluorouracil DRUG

TPFChemotherapy + Concomitant Cetuximab & RT

computed tomography PROCEDURE

TPFChemotherapy + Concomitant Cetuximab & RT

positron emission tomography PROCEDURE

TPFChemotherapy + Concomitant Cetuximab & RT

quality-of-life assessment PROCEDURE

TPFChemotherapy + Concomitant Cetuximab & RT

3-dimensional conformal radiation therapy RADIATION

TPFChemotherapy + Concomitant Cetuximab & RT

intensity-modulated radiation therapy RADIATION

TPFChemotherapy + Concomitant Cetuximab & RT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed (from primary lesion and/or lymph nodes) squamous cell carcinoma (SCC) of the head and neck, including the following subtypes:
• Oropharynx
• Hypopharynx
• Larynx
• Primary site of tumor must not include any of the following:
• Nasopharynx
• Sinuses
• Salivary glands
• Stage III or IV disease that is unresectable (oropharynx, larynx, or hypopharynx) OR that is resectable with organ-sparing goal (oropharynx or hypopharynx)
• Measurable disease by CT scan or MRI
• No definitive evidence of distant metastasis
• ECOG performance status 0-1
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 8 g/dL

You may not qualify if:

• History of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80
• Other invasive malignancy within the past 3 years, except nonmelanoma skin cancer
• Prior allergic reaction to the study drug(s)
• Concurrent uncontrolled illness including, but not limited to, any of the following:
• Ongoing or active infection
• Psychiatric illness/social situation that would limit compliance with study requirements
• Significant history of uncontrolled cardiac disease, including any of the following:
• Uncontrolled hypertension
• Unstable angina
• Myocardial infarction within the past 6 months
• Uncontrolled congestive heart failure
• Cardiomyopathy with decreased left ventricular ejection fraction (i.e., LVEF \< 45%)
• Uncontrolled condition that, in the opinion of the investigator, would interfere in the safe and timely completion of study procedures
• History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan
• HIV positivity

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab; Cisplatin; Docetaxel; Fluorouracil; Magnetic Resonance Spectroscopy; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Mercedes Porosnicu
• Organization: Wake Forest University Health Sciences

mporosni@wakehealth.edu

336-716-8664

Study Officials

• Mercedes Porosnicu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 24, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 7, 2020
• Results First Posted: July 12, 2019

Record last verified: 2020-03

Locations

US (1)