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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02209701
• Other study ID #: 1164.3
• Status: Terminated
• Phase: Phase 1
• First received: August 5, 2014
• Last updated: August 5, 2014
• Start date: December 1999

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. primary completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• Porfiromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of serum concentrations of the analyte		up to 6 hours after drug infusion	No
Primary	Amount of analyte excreted in urine		0-3 and 3-6 hours after infustion	No

External Links

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