Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126542
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2005-08-02
Brief Title:
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cavity Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bevacizumab NSC 704865 and OSI-774 NSC 718781 In Recurrent Ovarian Cancer Fallopian Tube Carcinoma or Primary Peritoneal 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 phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with recurrent or metastatic ovarian epithelial fallopian tube or primary peritoneal cavity cancer 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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving bevacizumab together with erlotinib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate in patients with recurrent or metastatic ovarian epithelial fallopian tube or primary peritoneal cavity cancer treated with bevacizumab and erlotinib
SECONDARY OBJECTIVES
I Determine the toxic effects of this regimen in these patients II Determine the median progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Patients also receive oral erlotinib once daily on days 1-21 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
I Determine the response rate in patients with recurrent or metastatic ovarian epithelial fallopian tube or primary peritoneal cavity cancer treated with bevacizumab and erlotinib
SECONDARY OBJECTIVES
I Determine the toxic effects of this regimen in these patients II Determine the median progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Patients also receive oral erlotinib once daily on days 1-21 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62203 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62203 |
| NCI-2012-02660 | REGISTRY | None | None |
| UCCRC-13576A | None | None | None |
| NCI-6759 | None | None | None |
| CDR0000434820 | None | None | None |
| 13576A | OTHER | None | None |
| 6759 | OTHER | None | None |
| N01CM62209 | NIH | None | None |
| P30CA014599 | NIH | None | None |
| N01CM62201 | NIH | None | None |