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

NCT ID: NCT04863144

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-02-01

Brief Summary

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

Detailed Description

population pharmacokinetic study in patients with normal or impaired liver functions, receiving paclitaxel for cancer treatment.

40 Patients with histologically confirmed solid tumors will be enrolled in the study:

• 20 patients have normal liver functions as defined by transaminase < 2.6 x ULN and bilirubin values < 1.26 x ULN.
• 20 patients with liver impairment as defined by transaminase 2.6 - 10 x ULN and bilirubin values 1.26 - 5 x ULN.

Conditions

Liver Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Blood samples

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Nour-Eldin, Professor

Role: STUDY_DIRECTOR

Pharmacology Department - Faculty of Medicine - Ain Shams University

Khaled Abdel-Aziz, MD

Role: STUDY_DIRECTOR

Oncology Department - Faculty of Medicine - Ain Shams University

Locations

El Demerdash Oncology Hospital

Cairo, Abbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed M Mohamed, Master

Role: CONTACT

dr_ahmed_mostafa@med.asu.edu.eg

01126109080

Facility Contacts

Ahmed M Mohamed, Master

Role: primary

dr_ahmed_mostafa@med.asu.edu.eg

01126109080

Other Identifiers

FMASU MD 8/2020

Identifier Type: -

Identifier Source: org_study_id