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

Sponsored by:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00665392

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: cetuximab Drug: cisplatin Drug: docetaxel Drug: fluorouracil	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Cisplatin Fluorouracil Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and 5FU (ETPF) for Squamous Cell Carcinoma of the Oropharynx That is Operable Stage III-IV

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete clinical response rate at 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of response (partial and complete response and stable disease) [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Pathologic response [ Designated as safety issue: No ]
Tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	February 2008
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

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

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

Locations

France
Hopital Tenon	Recruiting
Paris, France, 75970
Contact: Contact Person 33-1-5601-6246 jean.lacau@tnn.aphp.fr

Sponsors and Collaborators

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Principal Investigator:

Jean Lacau Saint Guily, MD

Hopital Tenon

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00665392
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Study placed in the following topic categories:

Docetaxel
Epidermoid carcinoma
Cisplatin
Fluorouracil
Squamous cell carcinoma
Head and Neck Neoplasms

Cetuximab
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009