Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin and major metabolites in head and neck cancer and other cancer patients with solid tumors who receive radiation therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Porfiromycin

Criteria

Inclusion Criteria:

• Patients with histologically proven advanced head and neck cancer or other solid tumors undergoing radiation therapy

• Patients with prior chemotherapy will be considered if chemotherapy occurred more than 30 days prior to this study

• Patients must be receiving concomitant radiotherapy (RT)

• Performance status of ≥ 70% on the Karnofsky performance scale (KPS)

• Must be ≥ 18 years of age

• Expected survival of at least three months

• Written informed consent

Exclusion Criteria:

• Patients who meet any of the following clinical laboratory criteria:

• Granulocyte count of < 2000/mm**3

• Platelets < 75,000/mm**3

• Serum creatinine > 1.5 times the upper limit of normal

• Bilirubin > 1.5 times the upper limit of normal

• Prothrombin time and partial thromboplastin time > 1.5 times the upper limit of normal

• Women who are pregnant

• Men and women of child-bearing potential who are unwilling to utilize a medically acceptable method of contraception

• Patients who have any known bleeding disorder at the discretion of the investigator

• Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependent chronic obstructive pulmonary disease, or unstable liver or renal disease

• Treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor or Interleukin-1l within 30 days prior to the start of RT

• Patients who have had prior exposure to mitomycin C or porfiromycin