Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415181
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2006-12-21
Brief Title:
Pharmacogenomics of Paclitaxel in Ovarian Cancer
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
The Pharmacogenomics of Paclitaxel in Patients With Ovarian Cancer Predictors of Toxicity and Response
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel chemotherapeutic drug Specifically we will study this in patients with ovarian cancer who receive paclitaxelcarboplatin chemotherapy after primary surgery
Detailed Description:
Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer The effect and toxicity is unpredictable in the individual patient Paclitaxel is removed eliminated from the organism by oxidation CYP2C8 is the enzyme mainly responsible P-glycoprotein Pgp is an efflux transport protein natural to the human organism Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance Paclitaxel is substrate for Pgp Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expressionfunction We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future
We want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes acute toxicityeg bone marrow suppression and neuropathy and response to treatmentie CA125 response progression free survival and overall survival The metabolic capacity is estimated using a sparse sampling approach applying advanced computerized pharmacokineticdynamic modelling as opposed to traditional frequent sampling pharmacokinetic studies which burden the individual patient more
Patients are recruited in collaboration with Oncological departments throughout Scandinavia
We want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes acute toxicityeg bone marrow suppression and neuropathy and response to treatmentie CA125 response progression free survival and overall survival The metabolic capacity is estimated using a sparse sampling approach applying advanced computerized pharmacokineticdynamic modelling as opposed to traditional frequent sampling pharmacokinetic studies which burden the individual patient more
Patients are recruited in collaboration with Oncological departments throughout Scandinavia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None