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

A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Drug: Porfiromycin

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Porfiromycin	Drug: Porfiromycin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 1999
• Primary Completion (Actual): July 1, 2000

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Antibiotics, Antineoplastic; Porfiromycin
• Other Study ID Numbers: 1164.3