Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278187
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2006-01-16
Brief Title:
Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Study of Volociximab M200 in Combination With Erlotinib Tarceva in Previously Treated Patients With Locally Advanced Stage IIIb or Metastatic Stage IV Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Monoclonal antibodies such as volociximab 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 Volociximab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving volociximab together with erlotinib may kill more tumor cells
PURPOSE This phase II trial is studying how well giving volociximab together with erlotinib works in treating patients with stage III or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving volociximab together with erlotinib works in treating patients with stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the response rate in patients with locally advanced stage IIIB or metastatic stage IV non-small cell lung cancer treated with volociximab and erlotinib hydrochloride
Secondary
Evaluate the time to disease progression and duration of response in patients treated with this regimen
Evaluate the safety of this drug regimen in these patients
Evaluate the pharmacokinetics this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive volociximab IV over 30 minutes once every 2 weeks and oral erlotinib hydrochloride daily for 52 weeks in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed at 3 and 6 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Evaluate the response rate in patients with locally advanced stage IIIB or metastatic stage IV non-small cell lung cancer treated with volociximab and erlotinib hydrochloride
Secondary
Evaluate the time to disease progression and duration of response in patients treated with this regimen
Evaluate the safety of this drug regimen in these patients
Evaluate the pharmacokinetics this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive volociximab IV over 30 minutes once every 2 weeks and oral erlotinib hydrochloride daily for 52 weeks in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed at 3 and 6 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| UCLA-0504066-01 | None | None | None |
| PDL-M200-1206 | None | None | None |