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NCT Number: NCT00665392

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Tongue Diseases Tongue Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Simone Veil, Montmorency, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/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

Treatment and study plan

Cisplatin

Drug

75 mg/m², day 1. 3 cycles

docetaxel

Drug

75 mg/m² Day 1. 3 cycles

Fluorouracil

Drug

750 mg/m² day 1 to day 5. 3 cycles

Cetuximab

Drug

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

Primary outcomes

  1. Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months

    Time frame: at 3 months after ETPF combination

    The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination

Secondary outcomes

  1. Complete Clinical Response (cCR)

    Time frame: at 3 months

    Clinical complete response (cCR) is defined by:

    • Disappearance of all clinical evidence of visible tumor,
    • Disappearance of all palpable residual infiltration,
    • Disappearance of all evidence of residual visible tumor on CT scan in pharynx and parapharyngeal space,
    • Complete symmetric remobilization of the tongue and amygdala.
    • Disappearance of pre-existing trismus.
    • Negative control biopsy.

    The evaluation of tumor response rate was assessed by computed tomography scan of the neck and chest at Baseline, then at 3 months from inclusion using RECIST1.0 criteria and clinical examination

  2. The 2-year Estimated Overall Survival (OS) Rate

    Time frame: 2 years

    2-year OS measured survival at 2 years from randomization.

  3. Pathologic Response

    Time frame: after surgery of the primary tumor

    On primary tumor resected : measure of persistence or not of tumoral lesion, histological type, size and quality of the excision piece

    A pathological complete response is defined as no viable tumour cells detected on histological examination post surgery.

  4. The 2-year Estimated Progression-free Survival (PFS)

    Time frame: 2 years

    2-year PFS measured survival at 2 years from randomization.

  5. Complete Radiological Response (rCR)

    Time frame: At 3 months after the end of 3 cycles of the ETPF combination

    Radiological response is defined according to RECIST 1.0 criteria:

    • Complete response (CR): disappearance of all target lesions
    • Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter,
    • Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target the appearance of one or more new lesions,
    • Stable disease (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started

Other outcomes

  1. Biomarkers Analysis - HPV Genotyping

    Time frame: correlative studies investigating HPV status in tumor and blood samples obtained prior to and after induction therapy were done for exploratory purposes as planned in the protocol

Sponsors and collaborators

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Other

Registry information

Official study title

Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx

Acronym: ECHO-07

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Apr 23, 2008
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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