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

Ain Shams University

Status: Unknown

Conditions: Liver Diseases

Treatments: Other: Blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT04863144

FMASU MD 8/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.