Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007904
Status:
COMPLETED
Last Update Posted:
2012-10-02
First Post:
2001-01-06
Brief Title:
Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Than or Equal to 10 Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2012-09
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of administering adjuvant paclitaxel dose-intensive cyclophosphamide and filgrastim G-CSF followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving 4 lymph nodes
Determine the incidence of febrile neutropenia in these patients during the first course of therapy
Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194
Determine the disease-free and overall survival of patients treated with this regimen
Evaluate the quality of life of these patients
Correlate HER-2neu overexpression with disease-free and overall survival in these patients
OUTLINE Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until day 14 or until blood counts recover Treatment repeats every 21 days for 3 courses Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses
Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy
Beginning 3-6 weeks after the completion of chemotherapy patients receive radiotherapy 5 days a week for 6-7 weeks
Quality of life is assessed days 1 and 4 of the first course of chemotherapy day 1 of the second course the last day of the final course and at 6 months after the completion of treatment
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 26 patients will be accrued for this study
Determine the feasibility of administering adjuvant paclitaxel dose-intensive cyclophosphamide and filgrastim G-CSF followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving 4 lymph nodes
Determine the incidence of febrile neutropenia in these patients during the first course of therapy
Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194
Determine the disease-free and overall survival of patients treated with this regimen
Evaluate the quality of life of these patients
Correlate HER-2neu overexpression with disease-free and overall survival in these patients
OUTLINE Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until day 14 or until blood counts recover Treatment repeats every 21 days for 3 courses Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses
Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy
Beginning 3-6 weeks after the completion of chemotherapy patients receive radiotherapy 5 days a week for 6-7 weeks
Quality of life is assessed days 1 and 4 of the first course of chemotherapy day 1 of the second course the last day of the final course and at 6 months after the completion of treatment
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 26 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-2010-01068 | OTHER | NCICTRP | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| 05-00-23 | OTHER | None | None |
| NCI-G00-1877 | None | None | None |
| CWRU1100 | OTHER | None | None |