Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Squamous Cell Head and Neck Carcinoma; Recurrent or Metastatic Disease
MeSH terms: Carcinoma; Neoplasm Metastasis; Recurrence
Intervention: cetuximab IV; Biopsies
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.; No intervention, only biopsy for translational project.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Squamous cell carcinoma of the head and neck; recurrent or metastatic; first line chemotherapy; cetuximab; docetaxel; cisplatin; antineoplastic agents; First Line Palliative Treatment

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.
    

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