- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00665392
Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer (ECHO-07)
Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Montmorency, France, 95160
- Hôpital Simone Veil
-
Paris, France, 75015
- Hopital Europeen Georges Pompidou
-
Paris, France, 75018
- Hôpital Bichat - Claude Bernard
-
Paris, France, 75970
- Hopital Tenon
-
Paris, France, 75014
- Hôpital Privé St Joseph
-
Pierre Benite, France, 69495
- Centre Hospitalier Lyon Sud
-
Saint Cloud, France, 92100
- Centre René Huguenin
-
Suresnes, France, 92151
- Hopital Foch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cetuximab
Cetuximab by intravenous (IV) infusion over 1-2 h on day
|
75 mg/m², day 1. 3 cycles
75 mg/m² Day 1. 3 cycles
750 mg/m² day 1 to day 5. 3 cycles
400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 3 months after ETPF combination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Clinical Response (cCR)
Time Frame: at 3 months
|
Clinical complete response (cCR) is defined by:
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 |
at 3 months
|
The 2-year Estimated Overall Survival (OS) Rate
Time Frame: 2 years
|
2-year OS measured survival at 2 years from randomization.
|
2 years
|
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. |
after surgery of the primary tumor
|
The 2-year Estimated Progression-free Survival (PFS)
Time Frame: 2 years
|
2-year PFS measured survival at 2 years from randomization.
|
2 years
|
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:
|
At 3 months after the end of 3 cycles of the ETPF combination
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean Lacau Saint Guily, MD, Hopital Tenon
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Docetaxel
- Cisplatin
- Fluorouracil
- Cetuximab
Other Study ID Numbers
- CDR0000593027
- GERCOR-ECHO-07-1 (Other Identifier: GERCOR)
- 2007-002116-25 (EudraCT Number)
- EU-20838 (Registry Identifier: EU Clinical Trials Register)
- MERCK-GERCOR-ECHO-07-1 (Other Identifier: GERCOR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on cisplatin
-
West China Second University HospitalRecruitingNeoadjuvant Chemotherapy | Epithelial Carcinoma, OvarianChina
-
Insmed IncorporatedCompletedOsteosarcoma MetastaticUnited States
-
Privo TechnologiesNational Cancer Institute (NCI)CompletedOral Squamous Cell CarcinomaUnited States
-
Samsung Medical CenterUnknownNasophayngeal Carcinoma Between Stage II and IVbKorea, Republic of
-
Cedars-Sinai Medical CenterRecruitingHPV Positive Oropharyngeal Squamous Cell CarcinomaUnited States
-
Korea Cancer Center HospitalCompletedCervical CancersKorea, Republic of
-
Taiho Oncology, Inc.Quintiles, Inc.Completed
-
Sun Yat-sen UniversityActive, not recruitingNasopharyngeal CarcinomaChina
-
Lawson Health Research InstituteRecruitingLocally Advanced Head and Neck Squamous Cell CarcinomaCanada
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People... and other collaboratorsActive, not recruitingNasopharyngeal Carcinoma | Nasopharyngeal Neoplasms | Nasopharyngeal Diseases | Head and Neck NeoplasmChina