Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201760
Status:
COMPLETED
Last Update Posted:
2017-12-27
First Post:
2005-09-12
Brief Title:
Gemcitabine Trastuzumab and Gemcitabine Cisplatin Trastuzumab in Patients With Metastatic Breast Cancer
Sponsor:
Kari Kendra
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Randomized Phase II Study of Gemcitabine Trastuzumab and Gemcitabine Cisplatin Trastuzumab in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-11
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 study determines the proportion of metastatic breast cancer patients progression free after 6 months when treated with gemcitabine cisplatin trastuzumab or gemcitabine trastuzumab
Detailed Description:
Rationale Previous studies have demonstrated the anti-tumor efficacy of gemcitabine and trastuzumab against metastatic breast cancer when given alone and in combination Yet research indicates that the two drugs given together work more effectively than either alone Laboratory studies testing the combination of trastuzumab and cisplatin have shown synergistic anti-tumor activity with the two drugs In addition clinical studies suggest a high level of anti-tumor activity with the combination of gemcitabine and cisplatin Researchers are testing the triple drug combination of gemcitabine trastuzumab and cisplatin in the current study to evaluate the potential for enhanced responsiveness in patients with Her-2neu overexpressing breast cancer as well as comparing it to the double drug combination of gemcitabine and trastuzumab
Purpose This study will measure patient responses and compare the efficacy of a double drug combination gemcitabine and trastuzumab with a triple drug combination gemcitabine trastuzumab and cisplatin in patients with metastatic breast cancer Side effects will be carefully assessed in patients
Treatment Patients in this study will receive one of two treatment combinations A computer will randomly assign patients to a treatment group Group one will be given gemcitabine and trastuzumab Gemcitabine will be given to patients on days 1 and 8 and trastuzumab on days 1 8 and 15 Group two will receive gemcitabine trastuzumab and cisplatin Gemcitabine and cisplatin will both be administered on days 1 and 8 and trastuzumab on days 1 8 and 15 Each treatment cycle for both groups will last a total of 21 days All study drugs will be administered through intravenous infusions Several tests and exams will be given throughout the study to closely monitor patients Thorough patient exams will be given at the beginning of each treatment cycle Imaging tests will be done every two cycles for the first eight cycles and then every three cycles until study completion Study treatment will be discontinued due to disease growth or unacceptable side effects
Purpose This study will measure patient responses and compare the efficacy of a double drug combination gemcitabine and trastuzumab with a triple drug combination gemcitabine trastuzumab and cisplatin in patients with metastatic breast cancer Side effects will be carefully assessed in patients
Treatment Patients in this study will receive one of two treatment combinations A computer will randomly assign patients to a treatment group Group one will be given gemcitabine and trastuzumab Gemcitabine will be given to patients on days 1 and 8 and trastuzumab on days 1 8 and 15 Group two will receive gemcitabine trastuzumab and cisplatin Gemcitabine and cisplatin will both be administered on days 1 and 8 and trastuzumab on days 1 8 and 15 Each treatment cycle for both groups will last a total of 21 days All study drugs will be administered through intravenous infusions Several tests and exams will be given throughout the study to closely monitor patients Thorough patient exams will be given at the beginning of each treatment cycle Imaging tests will be done every two cycles for the first eight cycles and then every three cycles until study completion Study treatment will be discontinued due to disease growth or unacceptable side effects
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