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

NCT00665392 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-08-01

Study results available
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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.

Conditions

Interventions

DRUG

cisplatin

75 mg/m², day 1. 3 cycles

DRUG

docetaxel

75 mg/m² Day 1. 3 cycles

DRUG

fluorouracil

750 mg/m² day 1 to day 5. 3 cycles

DRUG

Cetuximab

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

Sponsors & Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Jean Lacau Saint Guily, MD · Hopital Tenon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-01
Primary Completion
2012-02-01
Completion
2013-11-01

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665392 on ClinicalTrials.gov