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Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer (ECHO-07)

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cisplatin
docetaxel
fluorouracil
Cetuximab
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Simone Veil
  • Hôpital Privé St Joseph
  • Hopital Europeen Georges Pompidou
  • Hopital Bichat - Claude Bernard
  • Hopital Tenon
  • centre Hospitalier Lyon Sud
  • Centre René Huguenin
  • Hopital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cetuximab

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2008
Last Updated
June 3, 2021
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00665392
Brief Title
Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer
Acronym
ECHO-07
Official Title
Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cetuximab
Arm Type
Experimental
Arm Description
Cetuximab by intravenous (IV) infusion over 1-2 h on day
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
75 mg/m², day 1. 3 cycles
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
75 mg/m² Day 1. 3 cycles
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
750 mg/m² day 1 to day 5. 3 cycles
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Primary Outcome Measure Information:
Title
Clinical and Radiological Complete Clinical Response (crCR) Rate at 3 Months
Description
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
Time Frame
at 3 months after ETPF combination
Secondary Outcome Measure Information:
Title
Complete Clinical Response (cCR)
Description
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
Time Frame
at 3 months
Title
The 2-year Estimated Overall Survival (OS) Rate
Description
2-year OS measured survival at 2 years from randomization.
Time Frame
2 years
Title
Pathologic Response
Description
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.
Time Frame
after surgery of the primary tumor
Title
The 2-year Estimated Progression-free Survival (PFS)
Description
2-year PFS measured survival at 2 years from randomization.
Time Frame
2 years
Title
Complete Radiological Response (rCR)
Description
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
Time Frame
At 3 months after the end of 3 cycles of the ETPF combination
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Lacau Saint Guily, MD
Organizational Affiliation
Hopital Tenon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Simone Veil
City
Montmorency
ZIP/Postal Code
95160
Country
France
Facility Name
Hôpital Privé St Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92100
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.gov/ct2/show/NCT00665392
Description
Related Info

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

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