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The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Probing CYP 3A4 activity | metabolite ratio of 6-α-hydroxypaclitaxel/paclitaxel | predose till 6 hours post infusion of paclitaxel |
| Probing CYP 2C8 activity | metabolite ratio of 3'-p-hydroxypaclitaxel/paclitaxel |
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Inclusion Criteria:
Exclusion Criteria:
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40 Patients with histologically confirmed solid tumors and are going to receive paclitaxel
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Mohamed, Master | Contact | 01126109080 | dr_ahmed_mostafa@med.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Demerdash Oncology Hospital | Recruiting | Cairo | Abbasia | 11865 | Egypt |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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plasma
| predose till 6 hours post infusion of paclitaxel |
| Incidence of adverse effects | Complete blood count, liver functions and neuropathy evaluation (according to Common Terminology Criteria for Adverse Events (CTCAE), version 5) will be assessed | baseline ( before first dose) till 100 days after the first dose |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |