Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

• Status: Terminated
• Trial end date: 2016-06-07
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: University of Miami
• Treatments: Cetuximab; Docetaxel

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.