Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
Condition: Squamous Cell Carcinoma; Head and Neck Cancer; Recurrent Disease
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Recurrence
Intervention: Erbitux; Taxotere; Low Dose Fractionated Radiation Therapy
Intervention description: Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.; Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.; Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Intervention MeSH terms: Docetaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Healthy volunteers: No
Keywords: SCCHN; Head and Neck Cancer; Squamous Cell Carcinoma; Recurrent

Summary:

      Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of
      patients with recurrent unresectable head and neck squamous cell carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have pathologically confirmed recurrence (reappearance of previously
             cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may
             have experienced more than one recurrence as long as the first recurrence occurred ≥ 6
             months following the end of the prior RT.

          2. The recurrence must have defined bi- or uni-dimensional measurements.

          3. Recurrence must be confined to the head and neck above the clavicles (loco-regional
             recurrence).

          4. The patient must not be a candidate for surgical resection.

          5. Patients must be at least 6 months from completion of prior chemotherapy and radiation
             therapy.

          6. Patients may have received prior chemotherapy as a component of their primary
             treatment, but not for recurrent disease.

          7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          8. Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl,
             creatinine < 1.5 mg/dl within 3 weeks prior to registration.

          9. Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase
             (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If > 2 x
             normal, liver ultrasound or CT is required to exclude metastases. If negative for
             metastases, patients are eligible.

         10. Patients must sign a study-specific informed consent form prior to study entry.

        Exclusion Criteria:

          1. Distant metastases outside of the head and neck.

          2. Primary disease in the nasopharynx or the salivary gland.

          3. Other concurrent invasive malignancies.

          4. Prior invasive malignancy unless disease free for at least two years (except prior in
             situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are
             permissible).

          5. Intercurrent medical illnesses which would impair patient tolerance to therapy or
             limit survival.

          6. Pre-existing grade ≥ 2 peripheral sensory neuropathy

          7. Pregnant and nursing women are excluded because of the potential teratogenic effects
             and potential unknown effects on nursing newborns.

          8. Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug
             with formulated with Polysorbate 80.