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NCT00080028 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00080028
Other study ID # PCYC-0210
Secondary ID
Status Terminated
Phase Phase 1
First received March 22, 2004
Last updated May 4, 2007

Study information
Verified date May 2007
Source Pharmacyclics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 18
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Motexafin Gadolinium Injection

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina
United States University of Texas, San Antonio Health Science Center San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

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