Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466687
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2007-04-25
Brief Title:
Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
A Phase II Trial of Tarceva Erlotinib and Avastin Bevacizumab in the Treatment of Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2013-07
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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth 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 carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving erlotinib together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IV melanoma
PURPOSE This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the overall response rate response duration and frequency of progression-free survival at 6 months in patients with stage IV melanoma treated with erlotinib hydrochloride and bevacizumab
Determine objective responses in patients treated with this regimen
Secondary
Determine the overall safety and tolerability of this regimen in these patients
Evaluate tissue blocks for EGFR by monoclonal antibody H11 DAKO or fluorescence in situ hybridizationFISH7p12-specific probe-overexpression or amplification in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral erlotinib hydrochloride once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo tissue collection to analyze EGFR by monoclonal antibody H11 DAKO or fluorescence in situ hybridization FISH 7p12-specific probe-overexpression or amplification Biological markers AKT MAPK p27 p21 CD13 CD34 and factor VIII are also measured
After completion of study treatment patients are followed periodically
Primary
Determine the overall response rate response duration and frequency of progression-free survival at 6 months in patients with stage IV melanoma treated with erlotinib hydrochloride and bevacizumab
Determine objective responses in patients treated with this regimen
Secondary
Determine the overall safety and tolerability of this regimen in these patients
Evaluate tissue blocks for EGFR by monoclonal antibody H11 DAKO or fluorescence in situ hybridizationFISH7p12-specific probe-overexpression or amplification in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral erlotinib hydrochloride once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients undergo tissue collection to analyze EGFR by monoclonal antibody H11 DAKO or fluorescence in situ hybridization FISH 7p12-specific probe-overexpression or amplification Biological markers AKT MAPK p27 p21 CD13 CD34 and factor VIII are also measured
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| VU-IRB-040468 | None | None | None |
| VU-VICC-MEL-0418 | None | None | None |