Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
Conditions
Squamous Cell Carcinoma - Head and Neck - Recurrent Disease
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
SCCHN, Head and Neck Cancer, Squamous Cell Carcinoma, Recurrent
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Erbitux Type: Drug
Name: Taxotere Type: Drug
Name: Low Dose Fractionated Radiation Therapy Type: Radiation
Overall Status
Recruiting
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.
Detailed Description
The investigator's approach is based on the following reasons:

- Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest.

- LDFRT will render enhanced bax activation mediated mode of cell death.

- Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death.

- The toxicity profile is expected to be minimal.

Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- 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.

- The recurrence must have defined bi- or uni-dimensional measurements.

- Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).

- The patient must not be a candidate for surgical resection.

- Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.

- Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.

- ECOG performance status 0-2.

- Granulocytes >= 1500/mm3, platelets >= 100,000/mm3, serum bilirubin =< 1.5 mg/dl, creatinine < 1.5 mg/dl within 3 weeks prior to registration.

- LFT's ≤ 2 x normal (SGOT/SGPT/Alkaline Phosphatase).If > 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.

- Patients must sign a study-specific informed consent form prior to study entry

Exclusion Criteria:

- Distant metastases outside of the head and neck.

- Primary disease in the nasopharynx or the salivary gland.

- Other concurrent invasive malignancies.

- Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melatomatous skin cancer, etc. are permissible).

- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.

- Pre-existing grade ≥ 2 peripheral sensory neuropathy

- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
Location
University of Miami
Miami, Florida, United States
Status: Recruiting
Contact: Matthew C Abramowitz, MD - 305-243-4200 - mabramowitz@med.miami.edu
Start Date
May 2013
Sponsors
University of Miami
Source
University of Miami
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page