Overview
Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
Status:
Terminated
Terminated
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Boehringer IngelheimTreatments:
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