Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086957
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2004-07-08
Brief Title:
Gefitinib Trastuzumab and Docetaxel in Treating Patients With Metastatic Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase III Trial of ZD1839 Iressa Trastuzumab Herceptin and Docetaxel Taxotere in Patients With erbB-2 HER-2 Overexpressing Stage IV Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-01
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 Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Combining gefitinib and trastuzumab with docetaxel may kill more tumor cells
PURPOSE This phase III trial is studying the best dose of docetaxel when given together with gefitinib and trastuzumab in treating patients with metastatic breast cancer
PURPOSE This phase III trial is studying the best dose of docetaxel when given together with gefitinib and trastuzumab in treating patients with metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and efficacy of gefitinib trastuzumab Herceptin and docetaxel in terms of time to disease progression in patients with HER2neu-overexpressing metastatic adenocarcinoma of the breast
Secondary
Determine the objective tumor response rate in patients treated with this regimen
Correlate expression andor degree of phosphorylation of epidermal growth factor receptor HER2neu c-fos Akt ERK½ P13K p53 p21 and p27 with outcome in patients treated with this regimen
OUTLINE This is a phase I multicenter dose-escalation study of docetaxel followed by a phase II study Patients are stratified according to trastuzumab Herceptin-naive vs trastuzumab-failure
Phase I Patients receive oral gefitinib once daily on days 2-14 Patients also receive trastuzumab IV over 30-90 minutes and docetaxel IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
NOTE Trastuzumab is given at a higher dose loading dose in course 1 and then at a lower dose in subsequent courses
Cohorts of 3-6 patients receive docetaxel at dose level 1 If no dose-limiting toxicity DLT is observed in the first cohort of 3 patients the dose of docetaxel remains the same If 1 DLT is observed in the first cohort of 3 patients 3 additional patients are added for a total of 6 patients to dose level 1 If no further DLTs are observed at dose level 1 the dose of docetaxel remains the same If 2 of 3 or 2 of 6 patients experience DLT at dose level 1 the dose of docetaxel is considered above the maximum tolerated dose MTD and is subsequently reduced If 2 of 3 or 2 of 6 patients experience DLT at the reduced dose of docetaxel the study is stopped
Phase II Patients receive docetaxel at the MTD and gefitinib and trastuzumab as in phase I
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-76 patients will be accrued for this study within 26 months
Primary
Determine the safety and efficacy of gefitinib trastuzumab Herceptin and docetaxel in terms of time to disease progression in patients with HER2neu-overexpressing metastatic adenocarcinoma of the breast
Secondary
Determine the objective tumor response rate in patients treated with this regimen
Correlate expression andor degree of phosphorylation of epidermal growth factor receptor HER2neu c-fos Akt ERK½ P13K p53 p21 and p27 with outcome in patients treated with this regimen
OUTLINE This is a phase I multicenter dose-escalation study of docetaxel followed by a phase II study Patients are stratified according to trastuzumab Herceptin-naive vs trastuzumab-failure
Phase I Patients receive oral gefitinib once daily on days 2-14 Patients also receive trastuzumab IV over 30-90 minutes and docetaxel IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
NOTE Trastuzumab is given at a higher dose loading dose in course 1 and then at a lower dose in subsequent courses
Cohorts of 3-6 patients receive docetaxel at dose level 1 If no dose-limiting toxicity DLT is observed in the first cohort of 3 patients the dose of docetaxel remains the same If 1 DLT is observed in the first cohort of 3 patients 3 additional patients are added for a total of 6 patients to dose level 1 If no further DLTs are observed at dose level 1 the dose of docetaxel remains the same If 2 of 3 or 2 of 6 patients experience DLT at dose level 1 the dose of docetaxel is considered above the maximum tolerated dose MTD and is subsequently reduced If 2 of 3 or 2 of 6 patients experience DLT at the reduced dose of docetaxel the study is stopped
Phase II Patients receive docetaxel at the MTD and gefitinib and trastuzumab as in phase I
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-76 patients will be accrued for this study within 26 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 |
|---|---|---|---|
| CDR0000371908 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-03049 | None | None | None |
| ZENECA-1839US0274 | None | None | None |
| ZENECA-IRUSIRES0012 | None | None | None |