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

This study has been terminated.

Sponsor:

Information provided by:

Pharmacyclics

ClinicalTrials.gov Identifier:

NCT00080028

First received: March 22, 2004

Last updated: May 4, 2007

Last verified: May 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2004
Last Updated Date	May 4, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Official Title ^ICMJE	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 Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Head and Neck Cancer Oropharynx Cancer Larynx Cancer Hypopharynx Cancer
Intervention ^ICMJE	Drug: Motexafin Gadolinium Injection
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	18
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00080028
Other Study ID Numbers ^ICMJE	PCYC-0210
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Pharmacyclics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pharmacyclics
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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