Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079040
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2004-03-08
Brief Title:
Cisplatin Etoposide and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Cisplatin Plus Etoposide PE Plus Bevacizumab NSC 704865 for Previously Untreated Extensive Stage Small Cell Lung Cancer
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 phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer Drugs used in chemotherapy such as cisplatin and etoposide work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or deliver tumor-killing substances to them Giving chemotherapy with a monoclonal antibody may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to six month progression free survival in patients with previously untreated SCLC
II To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to survival and response rate
III To evaluate toxicity in patients with extensive small cell lung cancer treated with the combination of PE plus concurrent and sequential bevacizumab who have received no prior systemic chemotherapy
SECONDARY OBJECTIVES
I To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with Etoposide-Cisplatin plus concurrent sequential bevacizumab
II To determine if pre-treatment plasma VEGF is predictive of progression free survival and overall survival in advanced SCLC
III To determine whether elevated plasma levels of endothelial cell-specific proteins VCAM E-selectin reflective of chemotherapy or bevacizumab induced endothelial damage are useful markers in assessing response to EtoposideCisplatin plus concurrent sequential bevacizumab
IV To determine whether pre- and post-treatment plasma levels of basic fibroblast growth factor bFGF is predictive of progression free survival and overall survival or predictive of response to therapy
OUTLINE This is a multicenter study
Chemotherapy Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Bevacizumab therapy Beginning concurrently with chemotherapy patients receive bevacizumab IV over 90 minutes on day 1 Treatment repeats every 21 days for up to 17 courses 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks for up to 3 years from study entry
I To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to six month progression free survival in patients with previously untreated SCLC
II To evaluate the combination of PE plus concurrent and sequential bevacizumab with respect to survival and response rate
III To evaluate toxicity in patients with extensive small cell lung cancer treated with the combination of PE plus concurrent and sequential bevacizumab who have received no prior systemic chemotherapy
SECONDARY OBJECTIVES
I To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with Etoposide-Cisplatin plus concurrent sequential bevacizumab
II To determine if pre-treatment plasma VEGF is predictive of progression free survival and overall survival in advanced SCLC
III To determine whether elevated plasma levels of endothelial cell-specific proteins VCAM E-selectin reflective of chemotherapy or bevacizumab induced endothelial damage are useful markers in assessing response to EtoposideCisplatin plus concurrent sequential bevacizumab
IV To determine whether pre- and post-treatment plasma levels of basic fibroblast growth factor bFGF is predictive of progression free survival and overall survival or predictive of response to therapy
OUTLINE This is a multicenter study
Chemotherapy Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Bevacizumab therapy Beginning concurrently with chemotherapy patients receive bevacizumab IV over 90 minutes on day 1 Treatment repeats every 21 days for up to 17 courses 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks for up to 3 years from study entry
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 |
|---|---|---|---|
| NCI-2012-02944 | REGISTRY | None | None |
| ECOG-E3501 | None | None | None |
| E3501 | OTHER | None | None |
| E3501 | OTHER | None | None |
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |