Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms
Intervention: Radiotherapy; Paclitaxel; Carboplatin
Intervention description: 80 centigray (cGy) on Day 1 & 2 and 22 & 23 of chemotherapy; 225 mg/m2 intravenously over three hours on Days 1 and 22; Area under the curve (AUC) of 6 will be given intravenously over 30 minutes on days 1 and 22
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: head and neck; squamous cell carcinoma; squamous cell; carcinoma; paclitaxel; carboplatin; radiotherapy; induction therapy

Summary:

      This study utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four
      small doses of radiation, prior to other treatment (surgery or radiation). This study is
      evaluating if radiation as a chemoenhancer increases the response rate of initial therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients greater than 18 years of age.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

          3. Patients with pathologically documented bulky T2, III and IV squamous cell cancer of
             the head and neck (excluding M1 disease), within 2 months of diagnosis. Bulky T2
             tumors are defined as those that have a volume of disease greater than 35 cm3 as
             measured by CT or MRI scan (26).

          4. Patients will be medically fit for undergoing chemotherapy. Specifically:

               1. no evidence of active angina pectoris or ventricular arrhythmias; no myocardial
                  infarction within the last six months. (Patients with medically controlled
                  hypertension or congestive heart failure are eligible.)

               2. an absolute neutrophil count of > 1000/uL and platelet count > 100,000/microliter
                  (uL)

               3. serum total bilirubin < 1.5 mg/dL

               4. Creatinine Clearance greater than 50 ml/min

                  Using an actual or calculated creatinine clearance using the formula:

                  (140 - age) x (wgt in kg)*/(serum creatinine)x(72)*= multiply by 0.85 for females

               5. if a pre-existing grade I neuropathy exists, patients must be willing to risk
                  worsening neuropathy secondary to Paclitaxel. Patients with grade II or greater
                  neuropathy will be excluded from study.

               6. ability to give written, informed consent to participate in the trial.

          5. Patients will have measurable disease as determined by MRI or CT scan or evaluable
             disease determined by panendoscopy to be eligible for enrollment on this study.

        Exclusion Criteria:

          1. Pregnant females. Males and women of childbearing potential must use effective
             contraception in order to prevent pregnancy during therapy.

          2. Patients with a history of previous or current malignancy at other sites diagnosed
             within the last 5 years, with the exception of adequately treated carcinoma in-situ of
             the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of
             other malignancies, who remain free of recurrence or metastases for greater than five
             years are eligible.

          3. Patients with active infection will not be eligible for this protocol until the
             infection is treated and the symptoms have clinically resolved.

          4. Patients with a history of allergy to drugs utilizing Cremophor in the formulation.

          5. Prior induction chemotherapy, prior irradiation or surgery will not be allowed.

          6. Patients with metastatic disease will not be eligible for this study.

          7. Patients with grade II or greater peripheral neuropathy will be excluded from study.