NCT00665392: ECHO-07

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

Completed Phase 2 Results posted Last updated 1 August 2025

What this trial tests

Phase 2 trial testing cisplatin in Head and Neck Cancer in 42 participants. Completed in 1 November 2013.

Timeline

1 February 2008

Primary endpoint
1 February 2012

1 November 2013

Quick facts

Lead sponsor	GERCOR - Multidisciplinary Oncology Cooperative Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 February 2008
Primary completion	1 February 2012
Estimated completion	1 November 2013
Sites	8 locations across France

Drugs / interventions tested

• cisplatin (cisplatin) — full drug profile →
• docetaxel (Docetaxel) — full drug profile →
• fluorouracil — full drug profile →
• Cetuximab (cetuximab) — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Who can join

Adults 18 to 75, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Tumor response Rate - Tumor

Group	Value	95% CI
ETPF Administration	9

Tumor response rate - node

Group	Value	95% CI
ETPF Administration	8

Tumor response rate - Tumor and node

Group	Value	95% CI
ETPF Administration	4

Complete Clinical Response (cCR) Secondary · 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

Tumor response rate - tumor

Group	Value	95% CI
ETPF Administration	17

Tumor response rate - node

Group	Value	95% CI
ETPF Administration	15

Tumor response rate - Tumor and node

Group	Value	95% CI
ETPF Administration	13

The 2-year Estimated Overall Survival (OS) Rate Secondary · 2 years

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

Group	Value	95% CI
ETPF Administration	82

Pathologic Response Secondary · 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.

Group	Value	95% CI
ETPF Administration	9

The 2-year Estimated Progression-free Survival (PFS) Secondary · 2 years

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

Group	Value	95% CI
ETPF Administration	64

Complete Radiological Response (rCR) Secondary · 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 smal

Tumor response rate - Tumor

Group	Value	95% CI
ETPF Administration	14

Tumor response rate - Node

Group	Value	95% CI
ETPF Administration	8

Tumor response rate - Tumor and node

Group	Value	95% CI
ETPF Administration	4

Biomarkers Analysis - HPV Genotyping Secondary · 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

HPV16 - Positive

Group	Value	95% CI
ETPF Administration	17

HPV16 - Negative

Group	Value	95% CI
ETPF Administration	25

Adverse events — posted to ClinicalTrials.gov

Time frame: Until 1 month after the last administration. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ETPF Administration

Serious: 13/41 (32%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	ETPF Administration
Diarrhoea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Febrile aplasia	Infections and infestations	—
Infection at the portacath site	Infections and infestations	—
Hypovolaemia	Vascular disorders	—
Orthostatic hypotension	Cardiac disorders	—
Cardiac arrest	Cardiac disorders	—
Acute pancreatitis	Hepatobiliary disorders	—
Renal failure	Renal and urinary disorders	—
sepsis	Infections and infestations	—
Febrile neutropenia	Infections and infestations	—

Other adverse events (11 terms — click to expand)

Reaction	System	ETPF Administration
Anemia	Blood and lymphatic system disorders	—
Diarrhoea	Gastrointestinal disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Acne	Skin and subcutaneous tissue disorders	—
Nausea	Gastrointestinal disorders	—
Stomatitis	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Creatinine	Blood and lymphatic system disorders	—
Febrile neutropenia	Infections and infestations	—
Neuropathy peripheral	Nervous system disorders	—

Most-reported serious reactions: Diarrhoea, Vomiting, Febrile aplasia, Infection at the portacath site, Hypovolaemia, Orthostatic hypotension, Cardiac arrest, Acute pancreatitis.

Data from ClinicalTrials.gov NCT00665392 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Chibaudel B, Lacave R, Lefevre M, Soussan P, et al · · 2015 · cited 6× · PMID 25684313 · DOI 10.1002/cam4.408
2. Exploring the Therapeutic Implications of Co-Targeting the EGFR and Spindle Assembly Checkpoint Pathways in Oral Cancer.
   Calheiros-Lobo M, Silva JPN, Pinto B, Monteiro L, et al · · 2024 · cited 2× · PMID 39339232 · DOI 10.3390/pharmaceutics16091196