Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Head and Neck Cancer, Oropharynx Cancer, Larynx Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, SCCHN, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer, Soft palate Cancer, Tonsil Cancer, Base of tongue Cancer, Supraglottic Cancer, Glottic Cancer, Pyriform Sinus Cancer, Pharyngeal wall Cancer, Throat cancer
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Each patient must sign a study-specific informed consent form Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin Karnofsky Performance Status score of at least 60% Primary tumor at least 4 cm in diameter Exclusion Criteria: Laboratory Values of: Serum creatinine > 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min Serum total bilirubin > 1.5 times the upper limit of normal ALT (formerly SGPT) > 1.5 times the upper limit of normal Alkaline phosphatase > 1.5 times the upper limit of normal Absolute neutrophil count (ANC) < 1500/L Platelet count < 100,000/L 3+ or greater proteinuria on urinalysis and Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx Distant metastases Prior history of cancer at any site treated with radiotherapy and/or chemotherapy History of SCCHN diagnosed within 5 years of current diagnosis
Sites / Locations
- Duke University Medical Center
- University of Texas, San Antonio Health Science Center