Pharmacokinetics of Paclitaxel in Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment

NCT04863144 | Unknown

• 1 other identifier: FMASU MD 8/2020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.

Conditions

Liver Diseases

Keywords

Paclitaxel; Pharmacokinetics; Egypt

Outcome Measures

Primary Outcomes (3)

• plasma concentrations of paclitaxel

  determination of plasma concentration and pharmacokinetic analysis of paclitaxel

  predose till 6 hours post infusion of paclitaxel

• plasma concentrations of 6-α-hydroxypaclitaxel

  determination of plasma concentration and pharmacokinetic analysis of 6-α-hydroxypaclitaxel

  predose till 6 hours post infusion of paclitaxel

• plasma concentrations of 3'-p-hydroxypaclitaxel

  determination of plasma concentration and pharmacokinetic analysis of 3'-p-hydroxypaclitaxel

  predose till 6 hours post infusion of paclitaxel

Secondary Outcomes (3)

• Probing CYP 3A4 activity

  predose till 6 hours post infusion of paclitaxel

• Probing CYP 2C8 activity

  predose till 6 hours post infusion of paclitaxel

• Incidence of adverse effects

  baseline ( before first dose) till 100 days after the first dose

Interventions

Blood samples OTHER

Plasma concentrations of paclitaxel and its metabolites will be obtained during the first treatment cycle. The samples for paclitaxel analysis will be collected in ethylenediamine tetraacetic acid tubes at 7-time points: just before infusion, in the middle of the infusion, at the end of infusion, at 1, 2, 4 and 6 hours post-infusion.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 Patients with histologically confirmed solid tumors and are going to receive paclitaxel

You may qualify if:

• Patients with histologically proven non haematopoietic malignancy (ovarian, breast and lung cancer).
• Age between 18 and 70 years
• At least a 4-week interval between the last dose of previous chemotherapy protocol and registration (6 weeks in case of treatment with carboplatin).
• Glomerular filtration rate \> 60 ml/min
• An Eastern Cooperative Oncology Group performance status 0-2, a life expectancy of \> 12 weeks, adequate bone marrow function \[absolute neutrophil count (ANC) ≥ 1 X 109 and platelets ≥ 100 X 109\]
• Patient accessible for treatment and follow-up and written informed consent.

You may not qualify if:

• Prior treatment with paclitaxel or other taxanes.
• Pre-existing motor or sensory neurotoxicity \> grade 2 according to World Health Organization (WHO) criteria.
• Active infection or other serious underlying medical condition (including prior allergic reactions to Paclitaxel or the drug's constituents), dementia or significantly altered mental status, symptomatic brain or liver metastases, history of atrial or ventricular arrhythmias or congestive heart failure even if medically controlled, history of clinical and electrocardiographically documented myocardial infarction.
• Simultaneous use of any medication, dietary supplements, or other compounds known to inhibit affect the pharmacokinetics of paclitaxel.
• Patients with difficult blood sampling.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

El Demerdash Oncology Hospital

Cairo, Abbasia, 11865, Egypt

RECRUITING

Biospecimen

Retention: NONE RETAINED

plasma

MeSH Terms

Conditions

Liver Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ahmed Nour-Eldin, Professor

  Pharmacology Department - Faculty of Medicine - Ain Shams University

  STUDY DIRECTOR

• Khaled Abdel-Aziz, MD

  Oncology Department - Faculty of Medicine - Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Ahmed M Mohamed, Master

CONTACT

01126109080; dr_ahmed_mostafa@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 28, 2021
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

EG (1)