Ignite Creation Date:
2024-05-05 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00604461
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2008-01-17
Brief Title:
Carboplatin Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma MPM
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase III Trial of Carboplatin Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma MPM
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study was to evaluate how effective the combination of Carboplatin Bevacizumab Avastin and Pemetrexed Alimta is in the treatment of patients with Malignant Pleural Mesothelioma MPM A combination of cisplatin and pemetrexed is considered standard for this disease and typically off protocol patients would receive cisplatin or carboplatin and pemetrexed as standard of care
The planned length of the study first patient screened to last patient enrolled was 24 months The planned length of the entire study enrollment period the treatment period a follow-up period of at least 12 months was 36 months
The planned length of the study first patient screened to last patient enrolled was 24 months The planned length of the entire study enrollment period the treatment period a follow-up period of at least 12 months was 36 months
Detailed Description:
This was a planned Phase III dose escalation study Patients were enrolled in a cohort of 3
Eligible patients with unresectable pleural mesothelioma received frontline treatment consisting of carboplatin AUC 5 bevacizumab 15 mgkg and pemetrexed 500 mgm2 every 21 days Tier-1 Dose escalation continued to achieve a target dosage using carboplatin AUC 6 Tier-2 After a maximum of 6 treatment cycles non-progressing patients received maintenance therapy with bevacizumab and pemetrexed every 21 days to complete 1-year total treatment duration
Eligible patients with unresectable pleural mesothelioma received frontline treatment consisting of carboplatin AUC 5 bevacizumab 15 mgkg and pemetrexed 500 mgm2 every 21 days Tier-1 Dose escalation continued to achieve a target dosage using carboplatin AUC 6 Tier-2 After a maximum of 6 treatment cycles non-progressing patients received maintenance therapy with bevacizumab and pemetrexed every 21 days to complete 1-year total treatment duration
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AVF3483s | OTHER | Genentech | None |