Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN
Condition: Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Paclitaxel; Carboplatin
Intervention description: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.; 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.; AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks.
Intervention MeSH terms: Paclitaxel; Carboplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and neck cancer; Squamous cell carcinoma; Metastatic; Recurrent; Phase II; Carboplatin; Paclitaxel; Cetuximab

Summary:

      This is a non-randomized, open-label phase II trial of 38 patients with recurrent or
      metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
      status of 0-1 with good organ function and will be treated with six weekly cycles of
      carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating
      physician at their discretion may continue to treat with weekly cetuximab as maintenance
      until disease progression. The study is designed to evaluate whether this regimen improves
      median overall survival (OS) as compared to an historical control population treated with a
      platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for
      recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource
      intensive. Our study regimen has been used extensively for induction therapy and off-protocol
      in palliative care, but treatment outcomes have yet to be defined by a clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years old

          -  Histologically or cytologically confirmed recurrent or metastatic Squamous Cell
             Carcinoma of the Head and Neck (SCCHN). All primary sites are eligible excluding WHO
             type III or EBV nasopharyngeal (WHO type I and WHO type II allowed as long as they are
             EBV negative)

          -  ECOG performance status 0-1

          -  Adequate organ and marrow function as defined below. Laboratory tests should be
             completed within 14 days prior to registration: ANC greater than or equal to
             1,500/mm3, Platelets greater than or equal to 100,000/mm3, HgB greater than 9g/dL
             (acceptable to reach this by transfusion), Total bilirubin less than or equal to
             1.5mg/dL, Albumin greater than 2.5 g/dL, AST(SGOT)/ALT(SGPT) less than or equal to
             2.5X institutional upper limit of normal, alkaline phosphatase less than or equal to
             2.5 x upper limit of normal, GFR greater than 30 mL/min (by standard Cockroft and
             Gault formula or measured via 24 hour urine collection)

          -  Women of childbearing potential (WOCBP) with negative serum or urine pregnancy test
             within 7 days of D1 of treatment

          -  WOCBP and men must agree to use adequate contraception prior to study entry and for
             duration of treatment under this protocol; adequate contraception is defined as any
             medically recommended method (or combination of methods) per standard of care.

          -  Cancer must be considered incurable by the treating clinician

          -  Ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  History of prior cumulative exposure to > 300mg/m2 cisplatin, AUC of 18 of
             carboplatin, or their combined equivalent within one year prior to enrollment

          -  Surgery or radiation within the four weeks prior to D1 of treatment under this
             protocol

          -  Prior systemic chemotherapy unless it was part of definitive-intent (curative intent)
             treatment more than 6 months before study entry

          -  Other active, invasive malignancy requiring ongoing therapy or expected to require
             systemic therapy within two years; localized squamous cell carcinoma of the skin,
             basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other
             malignancies requiring locally ablative therapy only will not result in exclusion

          -  Pregnant or lactating female