Cetuximab and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Oropharynx Cancer That Can Be Removed by Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00665392
First received: April 22, 2008
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

RATIONALE: 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. 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. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF)for Squamous Cell Carcinoma of the Oropharynx That is Operable Stage III-IV

Resource links provided by NLM:


Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):

Primary Outcome Measures:
  • Complete clinical response rate at 3 months [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of response (partial and complete response and stable disease) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: from inclusion to first disease progression with chemotherapy ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From inclusion to patient's decease ] [ Designated as safety issue: No ]
  • Pathologic response [ Time Frame: after surgery of the primary tumor ] [ Designated as safety issue: No ]
    On primary tumor resected : measure of persistence or not of tumoral lesion, histological type, size and quality of the excision piece

  • Tolerability [ Time Frame: until 1 month after the last administration ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: February 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cetuximab Drug: cisplatin
75 mg/m², day 1. 3 cycles
Drug: docetaxel
75 mg/m² Day 1. 3 cycles
Drug: fluorouracil
750 mg/m² day 1 to day 5. 3 cycles
Drug: Cetuximab
400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.

Detailed Description:

OBJECTIVES:

Primary

  • To determine the complete clinical response rate at 3 months in patients with stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab, docetaxel, cisplatin, and fluorouracil.

Secondary

  • To determine the rate of tumor response.
  • To determine progression-free and overall survival.
  • To determine the rate of complete pathological response.
  • To assess the tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for 1 year and every 3 months for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oropharynx

    • Stage III (T3 or T1-2, N1-2, M0) or nonmetastatic stage IV (T4 or T1-3, N3, M0) disease
    • Resectable disease
  • Measurable or evaluable disease
  • Tumor tissue available

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • WHO performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Creatinine < 1.5 times upper limit of normal (ULN)
  • Creatinine clearance ≥ 60 mL/min
  • AST and ALT < 5 times ULN
  • Bilirubin < 1.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Affiliated with social security (including CMU)

Exclusion criteria:

  • Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the past 6 months
  • Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis, interstitial pneumopathy)
  • Other cancer within the past 5 years except for resected skin cancer, localized cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix
  • Auditory condition precluding the use of cisplatin
  • Contraindication due to psychological, social, or geographical reasons that may impede proper monitoring of treatment
  • Persons under guardianship or trusteeship, or prisoners of law

PRIOR CONCURRENT THERAPY:

  • No prior treatment, including chemotherapy or radiotherapy
  • No concurrent phenytoin, live attenuated vaccines, or parenteral aminoglycosides
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665392

Locations
France
Hôpital Simone Veil
Montmorency, France, 95160
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Tenon
Paris, France, 75970
Hôpital Privé St Joseph
Paris, France, 75014
centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre René Huguenin
Saint Cloud, France, 92100
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Principal Investigator: Jean Lacau Saint Guily, MD Hopital Tenon
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier: NCT00665392     History of Changes
Other Study ID Numbers: CDR0000593027, GERCOR-ECHO-07-1, EUDRACT 2007-002116-25, EU-20838, MERCK-GERCOR-ECHO-07-1
Study First Received: April 22, 2008
Last Updated: August 21, 2012
Health Authority: France: Committee of the Protection of the Persons
France: Agence Nationale de sécurité du médicament et des Produits de Santé (ANSM)

Keywords provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
tongue cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cetuximab
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014