Status:
TERMINATED
Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 radiati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02209701
Start Date
December 1 1999
Last Update
August 6 2014
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