Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101348
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2005-01-07
Brief Title:
Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Colorectal Head and Neck Pancreatic or Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I and Biologic Correlative Study of Erlotinib in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma
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 III trial studies the side effects best way to give and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together with or without bevacizumab works in treating patients with metastatic or unresectable kidney colorectal head and neck pancreatic or non-small cell lung cancer Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as cetuximab and 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 Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving erlotinib together with cetuximab andor bevacizumab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of erlotinib when combined with cetuximab in patients with metastatic or unresectable renal cell colorectal head and neck pancreatic or non-small cell lung cancer part 1
II Determine the MTD of bevacizumab when combined with cetuximab and erlotinib in these patients part 2
III Determine the toxic effects both quantitatively and qualitatively of these regimens in these patients
IV Determine the antitumor activity of these regimens in terms of tumor response short-term survival and progression-free survival in these patients
SECONDARY OBJECTIVES
I Compare preliminarily the toxicity and antitumor activity profiles of these regimens in these patients
OUTLINE This is an open-label multicenter dose-escalation study of erlotinib and bevacizumab
Part 1 Patients receive oral erlotinib once daily on days 1-28 Patients also receive cetuximab IV over 3 hours on day 1 and over 1 hour on days 8 15 and 22
Cohorts of 3-6 patients receive escalating doses of erlotinib 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
Part 2 Patients receive erlotinib as in part 1 at the MTD and cetuximab as in part 1 Patients also receive bevacizumab IV over 1½ hours on day 1 and over 1 hour on day 15
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the 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
In both groups courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed at 1 month
I Determine the maximum tolerated dose MTD of erlotinib when combined with cetuximab in patients with metastatic or unresectable renal cell colorectal head and neck pancreatic or non-small cell lung cancer part 1
II Determine the MTD of bevacizumab when combined with cetuximab and erlotinib in these patients part 2
III Determine the toxic effects both quantitatively and qualitatively of these regimens in these patients
IV Determine the antitumor activity of these regimens in terms of tumor response short-term survival and progression-free survival in these patients
SECONDARY OBJECTIVES
I Compare preliminarily the toxicity and antitumor activity profiles of these regimens in these patients
OUTLINE This is an open-label multicenter dose-escalation study of erlotinib and bevacizumab
Part 1 Patients receive oral erlotinib once daily on days 1-28 Patients also receive cetuximab IV over 3 hours on day 1 and over 1 hour on days 8 15 and 22
Cohorts of 3-6 patients receive escalating doses of erlotinib 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
Part 2 Patients receive erlotinib as in part 1 at the MTD and cetuximab as in part 1 Patients also receive bevacizumab IV over 1½ hours on day 1 and over 1 hour on day 15
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the 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
In both groups courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
After completion of study treatment patients are followed at 1 month
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 |
|---|---|---|---|
| P30CA054174 | NIH | CTEP | httpsreporternihgovquickSearchP30CA054174 |
| NCI-2012-02639 | REGISTRY | None | None |
| CDR0000401514 | None | None | None |
| NCI-6588 | None | None | None |
| CTRC-IDD-0332 | OTHER | None | None |
| 6588 | OTHER | None | None |
| U01CA069853 | NIH | None | None |