Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck
Condition: Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Taxotere; Oxaliplatin
Intervention description: Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.; Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
Intervention MeSH terms: Oxaliplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research study is for subjects with squamous cell cancer of the head and neck which is
      not solely treatable with surgery or radiation. This research study involves treatment with
      an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of
      this study is to assess the effectiveness of this combination of medications for this type of
      cancer.

      Approximately 54 subjects will take part in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed Head and Neck Squamous
             Cell Carcinoma which is metastatic or unresectable and for which standard curative or
             palliative measures do not exist or are no longer effective.

          -  Tissue from tumor must be available. This may be paraffin embedded tissue from
             previous biopsy/resection. If it is not available, a repeat biopsy must be performed.

          -  Age greater than or equal to 18 years

          -  ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to
             50%)

          -  Patients must have adequate organ and marrow function as defined below:

          -  leukocytes greater than or equal to 3,000/microliter

          -  hemoglobin greater than or equal to 8.0 g/dl

          -  absolute neutrophil count greater than or equal to 1,500/microliter

          -  platelets greater than or equal to 100,000/microliter

          -  total bilirubin within normal institutional limits

          -  creatinine within normal institutional limits OR creatinine clearance greater than or
             equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional
             normal

          -  If:

               -  ALK PHOS is less than or equal to ULN and AST or ALT is less than or equal to
                  ULN, patient is eligible.

               -  ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1x but less
                  than or equal to 1.5x, patient is eligible.

               -  ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1.5x but
                  less than or equal to 5x, patient is eligible.

               -  ALK PHOS is less than or equal to ULN and AST or ALT is greater than 5x ULN,
                  patient is ineligible.

               -  ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is less
                  than or equal to ULN, patient is eligible.

               -  ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is
                  greater than 1x but less than or equal to 1.5x, patient is eligible.

               -  ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is
                  greater than 1.5x but less than or equal to 5x, patient is ineligible.

               -  ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is
                  greater than 5x ULN, patient is ineligible.

               -  ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is less
                  than or equal to ULN,patient is eligible.

               -  ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is
                  greater than 1x but less than or equal to 1.5x, patient is ineligible.

               -  ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is
                  greater than 1.5x but less than or equal to 5x, patient is ineligible.

               -  ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is
                  greater than 5x ULN, patient is ineligible.

               -  ALK PHOS is greater than 5x ULN and AST or ALT is less than or equal to ULN,
                  patient is ineligible.

               -  ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1x but less than
                  or equal to 1.5x, patient is ineligible

               -  ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1.5x but less than
                  or equal to 5x, patient is ineligible

               -  ALK PHOS is greater than 5x ULN and AST or ALT is greater than 5x ULN, patient is
                  ineligible

          -  Patients with neuropathy < 1.

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Women of childbearing potential must have a negative pregnancy test

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
             the study

          -  Patients undergoing therapy with other investigational agents.

          -  Previous treatment involving regimen utilizing any of the protocol chemotherapeutic
             agents

          -  Patients with known brain metastases

          -  History of allergy to platinum compounds or to antiemetics appropriate for
             administration in conjunction with protocol-directed chemotherapy. Patients with a
             history of severe hypersensitivity reaction to Taxotere or Oxaliplatin or other drugs
             formulated with polysorbate 80

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, or unstable angina pectoris, or
             cardiac arrhythmia

          -  Pregnant and nursing women

          -  HIV-positive patients