Ignite Creation Date:
2024-05-05 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00541073
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2007-10-05
Brief Title:
Pemetrexed Cisplatin and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery
Sponsor:
Centre Oscar Lambret
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2009-07
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:
RATIONALE Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving pemetrexed together with cisplatin and vitamin B12 may kill more tumor cells
PURPOSE This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery
PURPOSE This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Define an individually adapted by dosage protocol of pemetrexed disodium cisplatin and vitamin B12 in patients with unresectable pleural mesothelioma
Secondary
Determine the relationship between pharmacokinetic and pharmacodynamic parameters hematologic and nonhematologic
Analyze the inter-individual pharmacokinetic variations and the influence of the covariables on the pharmacokinetics of pemetrexed disodium
Analyze the impact of pharmacogenetic MTHFR TS GSTpi ERCC1 XPD variations on the toxicity of pemetrexed disodium
Validate a strategy of adapting dosage
OUTLINE This is a multicenter study
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients also receive vitamin B12 intramuscularly on day -7 and then every 9 weeks until chemotherapy is completed
Blood samples are collected during the first and third courses of chemotherapy Samples are analyzed by pharmacogenetic MTHFR TS GSTpi ERCC1 xPD pharmacokinetic and other pharmacological methods
Primary
Define an individually adapted by dosage protocol of pemetrexed disodium cisplatin and vitamin B12 in patients with unresectable pleural mesothelioma
Secondary
Determine the relationship between pharmacokinetic and pharmacodynamic parameters hematologic and nonhematologic
Analyze the inter-individual pharmacokinetic variations and the influence of the covariables on the pharmacokinetics of pemetrexed disodium
Analyze the impact of pharmacogenetic MTHFR TS GSTpi ERCC1 XPD variations on the toxicity of pemetrexed disodium
Validate a strategy of adapting dosage
OUTLINE This is a multicenter study
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients also receive vitamin B12 intramuscularly on day -7 and then every 9 weeks until chemotherapy is completed
Blood samples are collected during the first and third courses of chemotherapy Samples are analyzed by pharmacogenetic MTHFR TS GSTpi ERCC1 xPD pharmacokinetic and other pharmacological methods
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COL-2006-04 | None | None | None |
| COL-ALIMESO | None | None | None |
| INCA-RECF0441 | None | None | None |