Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055913
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2003-03-06
Brief Title:
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Of Bevacizumab rhuMAb VEGF In Combination With OSI-774 For Patients With Recurrent Or Metastatic Cancer Of The Head And Neck
Status:
COMPLETED
Status Verified Date:
2018-10
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 III trial is to see if combining erlotinib with bevacizumab works better in treating patients who have recurrent or metastatic head and neck cancer Erlotinib may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth 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 Combining erlotinib with bevacizumab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when administered with erlotinib in patients with recurrent or metastatic head and neck cancer
II Determine the objective response rate and stable diseaseabsence of early progression in patients treated with this regimen
OUTLINE This is a dose-escalation study of bevacizumab followed by a randomized multicenter study
Phase I Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Course 1 is 28 days in length All subsequent courses are 21 days
Course 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28
Arm II Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28
All subsequent courses All patients receive bevacizumab as in arm II and oral erlotinib on days 1-21
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when administered with erlotinib in patients with recurrent or metastatic head and neck cancer
II Determine the objective response rate and stable diseaseabsence of early progression in patients treated with this regimen
OUTLINE This is a dose-escalation study of bevacizumab followed by a randomized multicenter study
Phase I Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Course 1 is 28 days in length All subsequent courses are 21 days
Course 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28
Arm II Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28
All subsequent courses All patients receive bevacizumab as in arm II and oral erlotinib on days 1-21
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62201 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62201 |
| NCI-2012-02520 | REGISTRY | None | None |
| CDR0000271444 | None | None | None |
| UCCRC-NCI-5701 | None | None | None |
| UCCRC-11956A | None | None | None |
| NCI-5701 | None | None | None |
| 11956A | OTHER | None | None |
| 5701 | OTHER | None | None |
| P30CA014599 | NIH | None | None |