Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080743
Status:
COMPLETED
Last Update Posted:
2009-08-06
First Post:
2004-04-07
Brief Title:
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
ZD1839 IRESSA In Tamoxifen-Resistant Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-08
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 Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant stopped responding to tamoxifen
PURPOSE This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen
PURPOSE This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen
Detailed Description:
OBJECTIVES
Primary
Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer treated with gefitinib with or without tamoxifen
Secondary
Determine the toxic effects of these regimens in these patients
Determine whether changes in fludeoxyglucose F 18 uptake by positron emission tomography scan and changes in plasma DNA levels are indicators of an early response to gefitinib in these patients
Determine the pharmacokinetics of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to population intent-to-treat population comprising all patients who receive 1 dose of treatment vs a subset of the intent-to-treat population excluding patients with nonmeasurableevaluable only disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tamoxifen once daily Beginning 14 days after the start of tamoxifen patients receive oral gefitinib once daily
Arm II Patients receive oral placebo once daily Beginning 14 days after the start of placebo patients receive oral gefitinib as in arm I
In both arms treatment continues for 26 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for 6 months
PROJECTED ACCRUAL A total of 46 patients 23 per treatment arm will be accrued for this study within 23 months
Primary
Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer treated with gefitinib with or without tamoxifen
Secondary
Determine the toxic effects of these regimens in these patients
Determine whether changes in fludeoxyglucose F 18 uptake by positron emission tomography scan and changes in plasma DNA levels are indicators of an early response to gefitinib in these patients
Determine the pharmacokinetics of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to population intent-to-treat population comprising all patients who receive 1 dose of treatment vs a subset of the intent-to-treat population excluding patients with nonmeasurableevaluable only disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tamoxifen once daily Beginning 14 days after the start of tamoxifen patients receive oral gefitinib once daily
Arm II Patients receive oral placebo once daily Beginning 14 days after the start of placebo patients receive oral gefitinib as in arm I
In both arms treatment continues for 26 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for 6 months
PROJECTED ACCRUAL A total of 46 patients 23 per treatment arm will be accrued for this study within 23 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 |
|---|---|---|---|
| DMS-0236 | None | None | None |
| ZENECA-IRUSIRES0162 | None | None | None |