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

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

This study has been terminated.

Study NCT00080028. Last updated on May 4, 2007. Information provided by Pharmacyclics

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Official Title ^†	Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck
Brief Summary	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.
Detailed Description
Study Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Head and Neck Cancer Oropharynx Cancer Larynx Cancer Hypopharynx Cancer
Intervention ^†	Drug: Motexafin Gadolinium Injection
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Terminated
Enrollment ^†	18
Start Date ^†
Completion Date
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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00080028
Organization ID	PCYC-0210
Secondary IDs ^††
Study Sponsor ^†	Pharmacyclics
Collaborators ^††
Investigators ^†
Information Provided By	Pharmacyclics
Verification Date	May 2007
First Received Date ^†	March 22, 2004
Last Updated Date	May 4, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.