Status:
UNKNOWN
Pharmacokinetics of Paclitaxel in Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment
Lead Sponsor:
Ain Shams University
Conditions:
Liver Diseases
Eligibility:
All Genders
18-70 years
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 enrolle...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04863144
Start Date
August 1 2020
End Date
February 1 2022
Last Update
April 28 2021
Active Locations (1)
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1
El Demerdash Oncology Hospital
Cairo, Abbasia, Egypt, 11865