Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients

Exclusion Criteria

• •Patients that received any prior chemotherapy including mitomycin-C or porfiromycin.
• •Treatment with granulocyte, granulocyte-macrophage stimulating factor (G-CSF, GM-CSF) or Interleukin-11 within 30 days prior to start of RT.
• •RT within the treatment field for any malignancy within the past five years.
• •Patients who had any gross (visible or palpable) residual disease left after surgery.
• •Patients who met any of the following clinical laboratory criteria upon screening:
• •1. Granulocyte (neutrophil) count of \< 1,500/cubic millimeters (mm3)
• •2. Platelets \< 75,000/mm3
• •3. Prothrombin time (PT) and partial thromboplastin time (PTT) \> 1.5 times the upper limit of normal (ULN) in seconds.
• •Women who were pregnant or nursing.
• •Women of childbearing potential who were unwilling to utilise a medically acceptable method of contraception (oral contraceptives, intrauterine devices, diaphragm or subdermal implants eg: Norplant®).
• •Other malignancies active within the past five years (other than basal or squamous cell carcinomas of the skin outside the planned radiation portals, or in situ carcinoma of the cervix).
• •The presence of more than one primary tumor or presence of distant metastases.
• •The presence of any other life-threatening illness, such a severe chronic lung, liver, or heart disease that would be expected to be fatal within five years, regardless of the patient's cancer status.
• •Patients who participated in a clinical trial with another investigational drug or treatment 30 days prior to screening.