Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415207
Status:
COMPLETED
Last Update Posted:
2011-08-08
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:
Pharmacogenomics of Paclitaxel in 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 retrospectively in patients who participated in clinical trials that are now closed All patients had ovarian cancer and received 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 will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion Genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database We expect to be able to find 300 available cases to study
We will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion Genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database We expect to be able to find 300 available cases to study
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