Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024154
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-09-13
Brief Title:
Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of Herceptin and ZD1839 Iressa NSC 715055 IND61187 in Patients With Metastatic Breast Cancer That Overexpresses HER2Neu erbB-2
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase II trial is studying how well giving trastuzumab together with gefitinib works in treating patients with HER2-positive breast cancer The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells Biological therapies such as gefitinib may also interfere with the growth of tumor cells and may enhance the effects of trastuzumab Combining trastuzumab with gefitinib may be an effective treatment for metastatic breast cancers with high amounts of HER2
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate duration of response and time to progression in patients with metastatic breast cancer that overexpresses HER2-neu treated with trastuzumab Herceptin and gefitinib
II Determine the phase II dose of gefitinib when given in combination with trastuzumab in these patients
III Determine the toxicity of this regimen in these patients IV Determine the 3- and 6-month progression-free survival of patients treated with this regimen
V Correlate response rates with plasma levels of circulating HER2 and tumor levels of epidermal growth factor receptor activated HER2 and HER2 receptors as measured by immunohistochemistry andor fluorescent in situ hybridization FISH in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of gefitinib The phase I portion of this study was open in only 5 ECOG institutions The phase I portion has been completed and the study is being opened in all ECOG-affiliated institutions
Phase I completed Patients receive trastuzumab Herceptin IV over 30-90 minutes once weekly and oral gefitinib once daily beginning on day 1
Cohorts of 3-6 patients receive escalating doses of gefitinib 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 Once the MTD is established additional patients are accrued to the phase II portion of the study and are treated at that dose
Phase II Patients receive oral gefitinib once daily at the MTD established in phase I and trastuzumab IV weekly until week 24 at which time trastuzumab is given every 3 weeks with daily gefitinib until disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until 2 years from study entry
I Determine the response rate duration of response and time to progression in patients with metastatic breast cancer that overexpresses HER2-neu treated with trastuzumab Herceptin and gefitinib
II Determine the phase II dose of gefitinib when given in combination with trastuzumab in these patients
III Determine the toxicity of this regimen in these patients IV Determine the 3- and 6-month progression-free survival of patients treated with this regimen
V Correlate response rates with plasma levels of circulating HER2 and tumor levels of epidermal growth factor receptor activated HER2 and HER2 receptors as measured by immunohistochemistry andor fluorescent in situ hybridization FISH in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of gefitinib The phase I portion of this study was open in only 5 ECOG institutions The phase I portion has been completed and the study is being opened in all ECOG-affiliated institutions
Phase I completed Patients receive trastuzumab Herceptin IV over 30-90 minutes once weekly and oral gefitinib once daily beginning on day 1
Cohorts of 3-6 patients receive escalating doses of gefitinib 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 Once the MTD is established additional patients are accrued to the phase II portion of the study and are treated at that dose
Phase II Patients receive oral gefitinib once daily at the MTD established in phase I and trastuzumab IV weekly until week 24 at which time trastuzumab is given every 3 weeks with daily gefitinib until disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until 2 years from study entry
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 |
|---|---|---|---|
| CDR0000068896 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E1100 | None | None | None |
| U10CA021115 | NIH | None | None |