Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susanne Arnold
• Collaborator: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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.