Status:
TERMINATED
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Lead Sponsor:
Pharmacyclics LLC.
Conditions:
Head and Neck Cancer
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00080028
Last Update
May 8 2007
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States
2
University of Texas, San Antonio Health Science Center
San Antonio, Texas, United States