Back to resultsPharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
Primary Purpose
Head and Neck Neoplasms
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Porfiromycin
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Porfiromycin
Arm Description
Outcomes
Primary Outcome Measures
Assessment of serum concentrations of the analyte
Amount of analyte excreted in urine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02209701
Brief Title
Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Study Start Date
December 1999 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Porfiromycin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Porfiromycin
Primary Outcome Measure Information:
Title
Assessment of serum concentrations of the analyte
Time Frame
up to 6 hours after drug infusion
Title
Amount of analyte excreted in urine
Time Frame
0-3 and 3-6 hours after infustion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
Learn more about this trial
Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
We'll reach out to this number within 24 hrs