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

This study has been terminated.

First Received: March 22, 2004 Last Updated: May 4, 2007 History of Changes

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Tonsils and Adenoids

Drug Information available for: Motexafin gadolinium Motexafin

U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Estimated Enrollment:

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

No publications provided

Study ID Numbers:	PCYC-0210
Study First Received:	March 22, 2004
Last Updated:	May 4, 2007
ClinicalTrials.gov Identifier:	NCT00080028 History of Changes
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

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Laryngeal Neoplasms
Motexafin gadolinium
Pharyngeal Diseases
Pharmacologic Actions
Hypopharyngeal Neoplasms

Photosensitizing Agents
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Therapeutic Uses
Head and Neck Neoplasms
Stomatognathic Diseases
Laryngeal Diseases
Dermatologic Agents
Oropharyngeal Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009