Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer

NCT ID: NCT00665392

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-01
• Study Completion Date: 2013-11-01

Brief Summary

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.

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.

Conditions

Head and Neck Cancer

Study Design

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

Study Groups

cetuximab

Cetuximab by intravenous (IV) infusion over 1-2 h on day

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

75 mg/m², day 1. 3 cycles

docetaxel

Intervention Type: DRUG

75 mg/m² Day 1. 3 cycles

fluorouracil

Intervention Type: DRUG

750 mg/m² day 1 to day 5. 3 cycles

Cetuximab

Intervention Type: DRUG

400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.

Interventions

cisplatin

75 mg/m², day 1. 3 cycles

Intervention Type: DRUG

docetaxel

75 mg/m² Day 1. 3 cycles

Intervention Type: DRUG

fluorouracil

750 mg/m² day 1 to day 5. 3 cycles

Intervention Type: DRUG

Cetuximab

400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• WHO performance status 0-1
• ANC ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Lacau Saint Guily, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Tenon

Locations

Hôpital Simone Veil

Montmorency, , France

Hôpital Privé St Joseph

Paris, , France

Hopital Europeen Georges Pompidou

Paris, , France

Hopital Bichat - Claude Bernard

Paris, , France

Hopital Tenon

Paris, , France

centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Centre René Huguenin

Saint-Cloud, , France

Hopital Foch

Suresnes, , France

Countries

France

References

Chibaudel B, Lacave R, Lefevre M, Soussan P, Antoine M, Perie S, Belloc JB, Banal A, Albert S, Chabolle F, Ceruse P, Baril P, Gatineau M, Housset M, Moukoko R, Benetkiewicz M, de Gramont A, Bonnetain F, Lacau St Guily J. Induction therapy with cetuximab plus docetaxel, cisplatin, and 5-fluorouracil (ETPF) in patients with resectable nonmetastatic stage III or IV squamous cell carcinoma of the oropharynx. A GERCOR phase II ECHO-07 study. Cancer Med. 2015 May;4(5):721-31. doi: 10.1002/cam4.408. Epub 2015 Feb 14.

Reference Type: RESULT

PMID: 25684313 (View on PubMed)

Other Identifiers

GERCOR-ECHO-07-1

Identifier Type: OTHER

Identifier Source: secondary_id

2007-002116-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EU-20838

Identifier Type: REGISTRY

Identifier Source: secondary_id

MERCK-GERCOR-ECHO-07-1

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000593027

Identifier Type: -

Identifier Source: org_study_id