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


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Oropharynx Cancer, Larynx Cancer, Hypopharynx Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0210

NCT ID:

NCT00080028

Start Date:

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Oropharynx Cancer
  • Larynx Cancer
  • Hypopharynx Cancer
  • 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
  • Laryngeal Neoplasms
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Oropharyngeal Neoplasms
  • Hypopharyngeal Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
University of Texas, San Antonio Health Science CenterSan Antonio, Texas