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Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (TPEx)

Primary Purpose

Squamous Cell Head and Neck Carcinoma, Recurrent or Metastatic Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cetuximab IV
Biopsies
Sponsored by
Groupe Oncologie Radiotherapie Tete et Cou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Head and Neck Carcinoma focused on measuring Squamous cell carcinoma of the head and neck, recurrent or metastatic, first line chemotherapy, cetuximab, docetaxel, cisplatin, antineoplastic agents, First Line Palliative Treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
  • Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
  • Measurable or evaluable disease
  • Age > 18 years and <= 70 years
  • WHO performance status 0 or 1
  • Absolute neutrophil count > 1,500/mm3
  • Platelets > 150,000/mm3
  • Total Bilirubin <= institutional upper limit of normal
  • Aspartate aminotransferase < 1.5 X institutional upper limit of normal
  • Alanine aminotransferase < 1.5 X institutional upper limit of normal
  • Alkaline phosphatase < 2.5 X institutional upper limit of normal
  • creatinine clearance > 60 mL/min
  • Signed informed consent
  • Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment

Exclusion Criteria:

  • Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed
  • Previous treatment with total doses of cisplatin > 300 mg/ m2
  • Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure
  • Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry
  • Nasopharyngeal carcinoma, or cancer of sinusal cavities
  • Active infection including tuberculosis or HIV positive patient
  • Other malignancy within last 5 years except for non-melanoma skin cancer
  • No other investigational agent within 30 days prior to study entry
  • No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications
  • No prior anti EGFR therapy
  • No known brain metastases
  • Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
  • Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis
  • No history of hypersensitivity reaction to drugs on study
  • No unstable angina or myocardial infarction within the past 12 months
  • No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease
  • No serious uncontrolled cardiac arrhythmia
  • No other prior or concomitant squamous cell carcinoma
  • No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years
  • Patient is pregnant or lactating
  • Patients must not have any co-existing condition that would preclude full compliance with the study

Sites / Locations

  • Cliniques Universitaires
  • Clinique Sainte Elisabeth
  • Clinique universitaire de Mont Godinne UCL
  • Hôpital Saint André
  • Centre Jean Perrin,
  • Centre G-F Leclerc
  • Centre Hospitalier de la Dracénie
  • Centre Hospitalier de Bretagne Sud
  • Centre Léon Bérard
  • Hôpital de la Timone
  • Centre Henri Becquerel
  • Hôpital Foch
  • CHU Bretonneau
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cetuximab

Arm Description

Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according

Outcomes

Primary Outcome Measures

Objective Tumor Response Rate
The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Secondary Outcome Measures

Grade 1 to 5 Toxicity
All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.
Best Overall Response
Tumor response is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.
Progression-free Survival
Overall Survival
Biomarkers

Full Information

First Posted
February 1, 2011
Last Updated
April 7, 2017
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01289522
Brief Title
Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Acronym
TPEx
Official Title
Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.
Detailed Description
OBJECTIVES: Primary To determine the efficacy of TPEx combination in patients with head and neck cancer in term of objective response rate (RECIST, see statistical consideration) Secondary To assess toxicities of TPEx combination Determine the efficacy of TPEx combination in patients with head and neck cancer: Best Overall Response , progression-free survival and survival. Translational research objective:To better understand the mechanisms of chemoresistance and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses. OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. Tumor check-up will be performed every 6 weeks. This study will allow translational research with blood sample and biopsies at baseline before any treatment, during the treatment with TPEx combination (week 6).,After completion of study treatment, patients are followed every 2 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Head and Neck Carcinoma, Recurrent or Metastatic Disease
Keywords
Squamous cell carcinoma of the head and neck, recurrent or metastatic, first line chemotherapy, cetuximab, docetaxel, cisplatin, antineoplastic agents, First Line Palliative Treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
cetuximab
Arm Type
Experimental
Arm Description
Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according
Intervention Type
Biological
Intervention Name(s)
cetuximab IV
Intervention Description
Cetuximab 400 mg/m² over 120 minutes on day 1 of cycle 1 only. Cetuximab dose will be 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. Cetuximab dose will be 500mg/m2 IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.
Intervention Type
Other
Intervention Name(s)
Biopsies
Intervention Description
No intervention, only biopsy for translational project.
Primary Outcome Measure Information:
Title
Objective Tumor Response Rate
Description
The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time Frame
12 weeks (after completion of the 4th cycle of chemotherapy)
Secondary Outcome Measure Information:
Title
Grade 1 to 5 Toxicity
Description
All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.
Time Frame
24 weeks (average)
Title
Best Overall Response
Description
Tumor response is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.
Time Frame
12 weeks
Title
Progression-free Survival
Time Frame
1 year
Title
Overall Survival
Time Frame
1 year
Title
Biomarkers
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease Measurable or evaluable disease Age > 18 years and <= 70 years WHO performance status 0 or 1 Absolute neutrophil count > 1,500/mm3 Platelets > 150,000/mm3 Total Bilirubin <= institutional upper limit of normal Aspartate aminotransferase < 1.5 X institutional upper limit of normal Alanine aminotransferase < 1.5 X institutional upper limit of normal Alkaline phosphatase < 2.5 X institutional upper limit of normal creatinine clearance > 60 mL/min Signed informed consent Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment Exclusion Criteria: Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed Previous treatment with total doses of cisplatin > 300 mg/ m2 Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry Nasopharyngeal carcinoma, or cancer of sinusal cavities Active infection including tuberculosis or HIV positive patient Other malignancy within last 5 years except for non-melanoma skin cancer No other investigational agent within 30 days prior to study entry No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications No prior anti EGFR therapy No known brain metastases Uncontrolled intercurrent illness that would prevent delivery of protocol therapy Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis No history of hypersensitivity reaction to drugs on study No unstable angina or myocardial infarction within the past 12 months No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease No serious uncontrolled cardiac arrhythmia No other prior or concomitant squamous cell carcinoma No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years Patient is pregnant or lactating Patients must not have any co-existing condition that would preclude full compliance with the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel GUIGAY
Organizational Affiliation
GORTEC
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires
City
Bruxelles
Country
Belgium
Facility Name
Clinique Sainte Elisabeth
City
Namur
Country
Belgium
Facility Name
Clinique universitaire de Mont Godinne UCL
City
Yvoir
Country
Belgium
Facility Name
Hôpital Saint André
City
Bordeaux
Country
France
Facility Name
Centre Jean Perrin,
City
Clermont-Ferrand
Country
France
Facility Name
Centre G-F Leclerc
City
Dijon
Country
France
Facility Name
Centre Hospitalier de la Dracénie
City
Draguignan
Country
France
Facility Name
Centre Hospitalier de Bretagne Sud
City
Lorient
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Hôpital Foch
City
Suresnes
Country
France
Facility Name
CHU Bretonneau
City
Tours
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26109631
Citation
Guigay J, Fayette J, Dillies AF, Sire C, Kerger JN, Tennevet I, Machiels JP, Zanetta S, Pointreau Y, Bozec Le Moal L, Henry S, Schilf A, Bourhis J. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Ann Oncol. 2015 Sep;26(9):1941-1947. doi: 10.1093/annonc/mdv268. Epub 2015 Jun 24.
Results Reference
derived

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Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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