Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck
Intervention: Abraxane; Cetuximab; Cetuximab; Cisplatin; 5-FU; Radiation (Post induction); Cisplatin; Cetuximab
Intervention description: 100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3; 400 mg/m2 IVPB, Day 1, cycle 1; 250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3; 75 mg/m2 IVPB Day 1, cycles 1, 2 and 3; 750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3; Monday-Friday, weeks 1-7; (Post induction) Cisplatin 100 mg/m2 IVPB on radiation day 1, 22 and 42; (Post-induction) Cetuximab (for patients who cannot receive cisplatin) will begin (+/- 3 days) before starting radiation therapy at 400 mg/m2 IVPB. Subsequent doses of cetuximab will be given weekly at 250 mg/m2 IVPB
Intervention MeSH terms: Cisplatin; Cetuximab; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase two trial will determine the tumor response rate at the primary site and at
      involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given
      in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.
    

Eligibility criteria:

        Inclusion

          -  Selected Stages 3 and 4a/b HNSCC: All patients must have T2-T4 primary tumors.
             Patients with T1 tumors will be excluded. Although most of these patients will have
             regional nodal disease, patients with no nodal disease will also be eligible.

          -  Oropharynx, hypopharynx, larynx, and oral cavity sub-sites only. Patients with
             nasopharyngeal, sinus and other sub-sites of the head and neck, or unknown primary SCC
             of the head and neck will NOT be eligible.

          -  Age ≥18 years

          -  Signed informed consent.

          -  ECOG Performance Status (PS) of 0-2 (Appendix 1).

          -  Adequate vital organ function (serum creatinine < 1.8 mg/dl, total bilirubin </= 1.5
             mg/dl, ALT and AST </= 2.5 x ULN, alkaline phosphatase </= 2.5 x ULN) and
             hematopoietic function (ANC >/= 1500/ul, Platelets > 100,000/ul, HGB > 9.0 g/dl).

          -  Patients with reproductive potential must use an effective method of contraception to
             avoid pregnancy for the duration of the trial and for three months after completing
             treatment.

          -  If female of childbearing potential, the patient must have a negative pregnancy test.

        Exclusion Criteria:

          -  Peripheral neuropathy > Grade 1.

          -  Prior chemotherapy, EGFR targeted therapy or radiation therapy for HNSCC.

          -  History of prior invasive malignancy diagnosed within the last three years other than
             local stage non-melanoma skin cancer.

          -  Be taking cimetidine or allopurinol. Patients must discontinue taking the medication
             for one week before receiving treatment with Abraxane.

          -  Be taking cimetidine or allopurinol. Patients must discontinue taking the medication
             for one week before receiving treatment with Abraxane.