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

Phase 1

Terminated

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Porfiromycin

• Registration Number: NCT02209701
• Lead Sponsor: Boehringer Ingelheim

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 radiation therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2000-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Study First Posted: 2014-08-06
• Last Update Posted: 2014-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Porfiromycin	Porfiromycin	-

Primary Outcome Measures

Name	Time	Method
Amount of analyte excreted in urine	0-3 and 3-6 hours after infustion
Assessment of serum concentrations of the analyte	up to 6 hours after drug infusion