Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027703
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2001-12-07
Brief Title:
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Double Blind Placebo Controlled Randomized Phase II Trial Of Gemcitabine And Cisplatin With Or Without The VEGF Inhibitor Bevacizumab NSC 704865 In Patients With Malignant Mesotheloma
Status:
COMPLETED
Status Verified Date:
2012-12
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 randomized phase II trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have malignant mesothelioma Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them It is not yet known if combination chemotherapy works better with or without bevacizumab in treating malignant mesothelioma
Detailed Description:
OBJECTIVES
I Compare the time to progression of patients with malignant mesothelioma treated with gemcitabine and cisplatin with or without bevacizumab
II Compare the objective response rate in patients treated with these regimens
III Compare the toxicity of these regimens when administered to these patients
IV Compare the median and overall survival of patients treated with these regimens
V Assess plasma vascular endothelial growth factor and serum vascular cell adhesion molecule-1 levels before during and after study therapy as predictors of outcome in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to histology epithelial vs other and ECOG performance status 0 vs 1 Patients are randomized to one of two treatment arms
ARM I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-60 minutes beginning after gemcitabine infusion and bevacizumab IV over 30-90 minutes beginning after cisplatin infusion on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease SD complete response CR or partial response PR after the sixth course may receive bevacizumab as a single agent once every 3 weeks in the absence of disease progression or unacceptable toxicity
ARM II Patients receive gemcitabine and cisplatin as in arm I and placebo IV over 30-90 minutes beginning after cisplatin infusion on day 1 Treatment repeats as in arm I Patients who achieve SD CR or PR after the sixth course may receive placebo as a single agent once every 3 weeks in the absence of disease progression
I Compare the time to progression of patients with malignant mesothelioma treated with gemcitabine and cisplatin with or without bevacizumab
II Compare the objective response rate in patients treated with these regimens
III Compare the toxicity of these regimens when administered to these patients
IV Compare the median and overall survival of patients treated with these regimens
V Assess plasma vascular endothelial growth factor and serum vascular cell adhesion molecule-1 levels before during and after study therapy as predictors of outcome in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to histology epithelial vs other and ECOG performance status 0 vs 1 Patients are randomized to one of two treatment arms
ARM I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-60 minutes beginning after gemcitabine infusion and bevacizumab IV over 30-90 minutes beginning after cisplatin infusion on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease SD complete response CR or partial response PR after the sixth course may receive bevacizumab as a single agent once every 3 weeks in the absence of disease progression or unacceptable toxicity
ARM II Patients receive gemcitabine and cisplatin as in arm I and placebo IV over 30-90 minutes beginning after cisplatin infusion on day 1 Treatment repeats as in arm I Patients who achieve SD CR or PR after the sixth course may receive placebo as a single agent once every 3 weeks in the absence of disease progression
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 |
|---|---|---|---|
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |
| NCI-2012-02430 | REGISTRY | None | None |
| CDR0000069058 | None | None | None |
| NCI-2710 | None | None | None |
| UCCRC-11046A | None | None | None |
| 11046A | OTHER | None | None |
| 2710 | OTHER | None | None |
| N01CM17102 | NIH | None | None |