Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

Pharmacyclics

Status and phase

Terminated

Phase 1

Conditions

Oropharynx Cancer

Hypopharynx Cancer

Larynx Cancer

Head and Neck Cancer

Treatments

Drug: Motexafin Gadolinium Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00080028

PCYC-0210

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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