Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074139
Status:
WITHDRAWN
Last Update Posted:
2014-03-05
First Post:
2003-12-10
Brief Title:
Docetaxel Doxorubicin and Cyclophosphamide in Treating Women With Advanced Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Pharmacokinetic Interaction Study Of Docetaxel Taxotere 75 mgmIV On The Combination Therapy Doxorubicin 50 mgm And Cyclophosphamide 50 mgm In The Treatment Of Advanced Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as docetaxel doxorubicin and cyclophosphamide use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them at different times may kill more tumor cells It is not yet known which combination chemotherapy regimen is more effective for breast cancer
PURPOSE Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer
PURPOSE Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the pharmacokinetic profile of docetaxel doxorubicin and cyclophosphamide in women with advanced breast cancer
Secondary
Compare the pharmacokinetic profile of this regimen in these patients vs the historical pharmacokinetic profile of docetaxel
OUTLINE This is a randomized open-label crossover multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 followed by doxorubicin IV over 15 minutes cyclophosphamide IV over 15 minutes and docetaxel IV over 1 hour on day 22
Arm II Patients receive doxorubicin IV over 15 minutes cyclophosphamide IV over 15 minutes and docetaxel IV over 1 hour on day 1 followed by doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 22
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity Patients may receive additional therapy at the discretion of the treating physician
Patients are followed at 3-4 weeks
PROJECTED ACCRUAL A total of 24 patients 12 per treatment arm will be accrued for this study within 7 months
Primary
Determine the pharmacokinetic profile of docetaxel doxorubicin and cyclophosphamide in women with advanced breast cancer
Secondary
Compare the pharmacokinetic profile of this regimen in these patients vs the historical pharmacokinetic profile of docetaxel
OUTLINE This is a randomized open-label crossover multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 followed by doxorubicin IV over 15 minutes cyclophosphamide IV over 15 minutes and docetaxel IV over 1 hour on day 22
Arm II Patients receive doxorubicin IV over 15 minutes cyclophosphamide IV over 15 minutes and docetaxel IV over 1 hour on day 1 followed by doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 22
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity Patients may receive additional therapy at the discretion of the treating physician
Patients are followed at 3-4 weeks
PROJECTED ACCRUAL A total of 24 patients 12 per treatment arm will be accrued for this study within 7 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 |
|---|---|---|---|
| AVENTIS-XRP6976D1001 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000343609 | REGISTRY | None | None |
| CWRU-AVEN-1103 | None | None | None |