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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: cisplatin; Drug: docetaxel; Drug: fluorouracil; Drug: Cetuximab

• Registration Number: NCT00665392
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

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.

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Results First Submitted: 2016-12-21
• Results First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Results First Posted: 2021-06-25
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cetuximab	cisplatin	Cetuximab by intravenous (IV) infusion over 1-2 h on day
cetuximab	docetaxel	Cetuximab by intravenous (IV) infusion over 1-2 h on day
cetuximab	fluorouracil	Cetuximab by intravenous (IV) infusion over 1-2 h on day
cetuximab	Cetuximab	Cetuximab by intravenous (IV) infusion over 1-2 h on day

Primary Outcome Measures

Name	Time	Method
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months	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 Outcome Measures

Name	Time	Method
The 2-year Estimated Progression-free Survival (PFS)	2 years	2-year PFS measured survival at 2 years from randomization.
Complete Radiological Response (rCR)	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
The 2-year Estimated Overall Survival (OS) Rate	2 years	2-year OS measured survival at 2 years from randomization.
Complete Clinical Response (cCR)	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
Pathologic Response	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.

Trial Locations

Locations (8)

Hopital Bichat - Claude Bernard; 🇫🇷 Paris, France

Hôpital Simone Veil; 🇫🇷 Montmorency, France

Hôpital Privé St Joseph; 🇫🇷 Paris, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Hopital Tenon; 🇫🇷 Paris, France

Centre René Huguenin; 🇫🇷 Saint Cloud, France

Hopital Foch; 🇫🇷 Suresnes, France