Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030446
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2002-02-14
Brief Title:
Erlotinib and Carboplatin in Recurrent Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study Of OSI-774 NSC 718781 Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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 Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib with carboplatin may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian fallopian tube or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the response rate in patients with recurrent ovarian epithelial fallopian tube or primary peritoneal cancer treated with erlotinib and carboplatin
Determine the duration of stable disease time to progression and response duration in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Correlate the level of epidermal growth factor receptor tumor expression with objective tumor response in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to response to prior platinum-containing therapy platinum-sensitive defined as 6 months or more since prior therapy with platinum agent closed to accrual as of 2132004 vs platinum-resistant defined as less than 6 months since prior therapy with platinum agent
Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on days 1-21 Treatment repeats every 21 days for up to 6 courses After the completion of 6 courses of therapy patients with responsive or stable disease may continue to receive erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 23-60 patients 8-30 for platinum-sensitive stratum closed to accrual as of 2132004 and 15-30 for platinum-resistant stratum will be accrued for this study within 15-23 months
Determine the response rate in patients with recurrent ovarian epithelial fallopian tube or primary peritoneal cancer treated with erlotinib and carboplatin
Determine the duration of stable disease time to progression and response duration in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Correlate the level of epidermal growth factor receptor tumor expression with objective tumor response in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to response to prior platinum-containing therapy platinum-sensitive defined as 6 months or more since prior therapy with platinum agent closed to accrual as of 2132004 vs platinum-resistant defined as less than 6 months since prior therapy with platinum agent
Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on days 1-21 Treatment repeats every 21 days for up to 6 courses After the completion of 6 courses of therapy patients with responsive or stable disease may continue to receive erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 23-60 patients 8-30 for platinum-sensitive stratum closed to accrual as of 2132004 and 15-30 for platinum-resistant stratum will be accrued for this study within 15-23 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069166 | OTHER | PDQ | None |
| CAN-NCIC-149 | OTHER | None | None |