Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054275
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2003-02-05
Brief Title:
Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
Sponsor:
Paula Silverman MD
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent AndOr Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-02
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 Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib with docetaxel may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer
PURPOSE Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer
Detailed Description:
OBJECTIVES
Determine the antitumor effects of erlotinib and docetaxel in terms of objective response stabilization of disease and progression-free survival in patients with stage IV or recurrent breast cancer
Determine time to tumor progression in patients treated with this regimen
Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib
OUTLINE Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1 Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression
Patients are followed for survival
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12-14 months
Determine the antitumor effects of erlotinib and docetaxel in terms of objective response stabilization of disease and progression-free survival in patients with stage IV or recurrent breast cancer
Determine time to tumor progression in patients treated with this regimen
Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib
OUTLINE Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1 Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression
Patients are followed for survival
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12-14 months
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 |
|---|---|---|---|
| CASE-CWRU-1102 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| 07-02-14M | OTHER | None | None |