A Study in Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Cetuximab; Cisplatin; Carboplatin; 5-Fluorouracil
Intervention description: Administered intravenously; Administered intravenously; Administered intravenously; Administered intravenously
Intervention MeSH terms: Carboplatin; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will begin with a 30 participant lead-in part: these 30 participants will receive
      cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy
      drugs [cisplatin or carboplatin plus 5-fluorouracil (5-FU)] administered every 3 weeks. After
      18 weeks, participants who benefit from this treatment may continue to receive cetuximab
      once-weekly until progression of the disease, an unacceptable side effect occurs,
      participants withdraw consent, or the study is closed.

      In the second part of this study, 200 participants will be randomized in 2 arms:

        -  100 participants will receive commercial cetuximab manufactured by ImClone (Group A)

        -  100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B).

      All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin
      plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this
      treatment may continue to receive cetuximab once-weekly until progression of the disease, an
      unacceptable side effect occurs, participants withdraw consent, or the study is closed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Head and neck cancer that was confirmed by tissue biopsy or cytology

          -  Disease not suitable for local therapy

          -  Measurable or evaluable disease

          -  Karnofsky performance status (KPS) score of at least 70

          -  Organs are functioning well (bone marrow reserve, liver and kidney)

          -  Life expectancy of at least 12 weeks

          -  Signed informed consent document

        Exclusion Criteria:

          -  Receiving another investigational medication within the last 30 days

          -  Prior chemotherapy, except if given as part of a multimodal treatment for locally
             advanced head and neck cancer that was completed more than 4 months prior to study
             entry.

          -  Nasopharyngeal carcinoma

          -  Previous treatment with monoclonal antibody therapy or other signal transduction
             inhibitors or epidermal growth factor receptor (EGFR) targeting therapy except for
             prior cetuximab treatment given as part of a multimodal treatment for locally advanced
             head and neck cancer that was completed more than 4 months prior to study entry.

          -  Uncontrolled high blood pressure

          -  Heart disease or had a heart attack within the last year

          -  Currently have an infection that requires for you to take an IV antibiotic

          -  Currently receiving other therapies for your cancer, such as chemotherapy, radiation
             therapy, immunotherapy, and hormonal therapy

          -  Medical or psychological condition that would not permit the participant to complete
             the study or sign informed consent

          -  Known drug abuse (with the exception of alcohol abuse)

          -  Known allergic reaction against any of the components of the study treatment

          -  Second primary malignancy that is clinically detectable at the time of consideration
             for study enrollment

          -  Have had another type of cancer within the last 2 years

          -  You are currently pregnant or breastfeeding

          -  You are considering becoming pregnant or fathering a child