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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT01289522
First received: February 1, 2011
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Squamous Cell Head and Neck Carcinoma
Recurrent or Metastatic Disease
Biological: cetuximab IV
Other: Biopsies
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 - GORTEC2008-03 TPEx

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • objective tumor response rate [ Time Frame: 12 weeks (after completion of the fourth cycle of chemotherapy) ] [ Designated as safety issue: No ]
    The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria


Secondary Outcome Measures:
  • Grade 1 to 5 toxicity [ Time Frame: 24 weeks (average) ] [ Designated as safety issue: Yes ]
    All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.

  • best overall response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Tumor response is evaluated every 6 weeks according to RECIST criteria

  • progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • biomarkers [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cetuximab
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
Biological: cetuximab IV
  • 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.

Other: Biopsies
No intervention, only biopsy for translational project.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289522

Locations
Belgium
Cliniques Universitaires
Bruxelles, Belgium
Clinique Sainte Elisabeth
Namur, Belgium
Clinique universitaire de Mont Godinne UCL
Yvoir, Belgium
France
Hôpital Saint André
Bordeaux, France
Centre Jean Perrin,
Clermont-Ferrand, France
Centre G-F Leclerc
Dijon, France
Centre Hospitalier de la Dracénie
Draguignan, France
Centre Hospitalier de Bretagne Sud
Lorient, France
Centre Léon Bérard
Lyon, France
Hôpital de la Timone
Marseille, France
Centre Henri Becquerel
Rouen, France
Hôpital Foch
Suresnes, France
CHU Bretonneau
Tours, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Study Chair: Joel GUIGAY GORTEC
  More Information

Additional Information:
GORTEC  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01289522     History of Changes
Other Study ID Numbers: GORTEC2008-03TPex, 2008-004869-25
Study First Received: February 1, 2011
Last Updated: January 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Squamous cell carcinoma of the head and neck
recurrent or metastatic
first line chemotherapy
cetuximab
docetaxel
cisplatin
antineoplastic agents
First Line Palliative Treatment

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Docetaxel
Cetuximab
Antineoplastic Agents
Cisplatin
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014