NCT00665392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Feb 2008

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

June 25, 2021

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

April 22, 2008

Results QC Date

December 21, 2016

Last Update Submit

July 22, 2025

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxtongue cancer

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (5)

  • Complete Clinical Response (cCR)

    at 3 months

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

    2 years

  • Pathologic Response

    after surgery of the primary tumor

  • The 2-year Estimated Progression-free Survival (PFS)

    2 years

  • Complete Radiological Response (rCR)

    At 3 months after the end of 3 cycles of the ETPF combination

Other Outcomes (1)

  • Biomarkers Analysis - HPV Genotyping

    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

Study Arms (1)

cetuximab

EXPERIMENTAL

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

Drug: cisplatinDrug: docetaxelDrug: fluorouracilDrug: Cetuximab

Interventions

cisplatinDRUG

75 mg/m², day 1. 3 cycles

cetuximab
docetaxelDRUG

75 mg/m² Day 1. 3 cycles

cetuximab
fluorouracilDRUG

750 mg/m² day 1 to day 5. 3 cycles

cetuximab
CetuximabDRUG

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

cetuximab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hôpital Simone Veil

Montmorency, 95160, France

Location

Hôpital Privé St Joseph

Paris, 75014, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Tenon

Paris, 75970, France

Location

centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre René Huguenin

Saint-Cloud, 92100, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Related Publications (1)

  • 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.

    PMID: 25684313RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckTongue Neoplasms

Interventions

CisplatinDocetaxelFluorouracilCetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeMouth NeoplasmsMouth DiseasesStomatognathic DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Regulatory Affairs
Organization
GERCOR
regulatory.affairs@gercor.com.fr
+33 (0)1 40 29 85 00

Study Officials

  • Jean Lacau Saint Guily, MD

    Hopital Tenon

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 23, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2012

Study Completion

November 1, 2013

Last Updated

August 1, 2025

Results First Posted

June 25, 2021

Record last verified: 2025-07

Locations

FR(8)