Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer Oropharynx Cancer Larynx Cancer Hypopharynx Cancer	Drug: Motexafin Gadolinium Injection	Phase I

MedlinePlus related topics:

Cancer Head and Neck Cancer

Drug Information available for:

Motexafin gadolinium Motexafin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck

Further study details as provided by Pharmacyclics:

Estimated Enrollment:

18

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080028

Locations


United States, North Carolina
	Duke University Medical Center
	Durham, North Carolina, United States

United States, Texas
	University of Texas, San Antonio Health Science Center
	San Antonio, Texas, United States

Sponsors and Collaborators

Pharmacyclics

More Information

Study ID Numbers:	PCYC-0210
First Received:	March 22, 2004
Last Updated:	May 4, 2007
ClinicalTrials.gov Identifier:	NCT00080028
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacyclics:

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

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms

Otorhinolaryngologic Diseases

Squamous cell carcinoma

Pharyngeal Neoplasms

Laryngeal Neoplasms

Motexafin gadolinium

Pharyngeal Diseases

Carcinoma

Epidermoid carcinoma

Hypopharyngeal Neoplasms

Respiratory Tract Diseases

Head and Neck Neoplasms

Carcinoma, squamous cell

Laryngeal carcinoma

Sinus cancer

Hypopharyngeal cancer

Laryngeal Diseases

Stomatognathic Diseases

Carcinoma, Squamous Cell

Carcinoma, squamous cell of head and neck

Oropharyngeal Neoplasms

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Photosensitizing Agents

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Pharmacyclics
Information provided by:	Pharmacyclics
ClinicalTrials.gov Identifier:	NCT00080028