Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004092
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Randomized Phase II Study of AdriamycinCytoxanTaxol ACT vs Cytoxan Thiotepa Carboplatin STAMP V in Patients With High-Risk Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-07
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 Combining more than one drug may kill more tumor cells
PURPOSE This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer
PURPOSE This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Compare the toxic effects of doxorubicin cyclophosphamide and paclitaxel vs cyclophosphamide thiotepa and carboplatin in patients with high-risk primary breast cancer Arm I closed to accural as of 462006
Compare the efficacies of these regimens followed by peripheral blood stem cell rescue in these patients
Determine the efficacy of a bisphosphonate to prevent relapsemetastasis after high-dose chemotherapy in these patients
OUTLINE This is a randomized study Patients are stratified by stage of disease
Peripheral blood stem cells PBSC are collected after mobilization with filgrastim G-CSF administered subcutaneously or IV twice daily beginning 3 days before collection and continuing until collection is complete
All patients receive conventional-dose adjuvant chemotherapy probably comprising doxorubicin IV cyclophosphamide IV and fluorouracil IV over 1 hour on days 1 22 43 and 64 Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy Arm I closed to accrual as of 462006
Arm I ACT closed to accrual as of 462006 Patients receive doxorubicin IV over 24 hours on days -9 to -6 cyclophosphamide IV over 2 hours on day -5 and paclitaxel IV over 24 hours on day -2 PBSC are reinfused on days -2 and 0 G-CSF is administered beginning on day 0 and continuing until blood counts recover
Arm II STAMP V Patients receive cyclophosphamide IV carboplatin IV and thiotepa IV over 24 hours on days -7 to -4 PBSC are reinfused and G-CSF is administered as in arm I
Within 4-6 weeks of day 0 of high-dose chemotherapy patients with estrogen andor progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years
Quality of life is assessed before therapy at 30 days after high-dose chemotherapy and at 6 and 12 months
Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 3 years
Compare the toxic effects of doxorubicin cyclophosphamide and paclitaxel vs cyclophosphamide thiotepa and carboplatin in patients with high-risk primary breast cancer Arm I closed to accural as of 462006
Compare the efficacies of these regimens followed by peripheral blood stem cell rescue in these patients
Determine the efficacy of a bisphosphonate to prevent relapsemetastasis after high-dose chemotherapy in these patients
OUTLINE This is a randomized study Patients are stratified by stage of disease
Peripheral blood stem cells PBSC are collected after mobilization with filgrastim G-CSF administered subcutaneously or IV twice daily beginning 3 days before collection and continuing until collection is complete
All patients receive conventional-dose adjuvant chemotherapy probably comprising doxorubicin IV cyclophosphamide IV and fluorouracil IV over 1 hour on days 1 22 43 and 64 Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy Arm I closed to accrual as of 462006
Arm I ACT closed to accrual as of 462006 Patients receive doxorubicin IV over 24 hours on days -9 to -6 cyclophosphamide IV over 2 hours on day -5 and paclitaxel IV over 24 hours on day -2 PBSC are reinfused on days -2 and 0 G-CSF is administered beginning on day 0 and continuing until blood counts recover
Arm II STAMP V Patients receive cyclophosphamide IV carboplatin IV and thiotepa IV over 24 hours on days -7 to -4 PBSC are reinfused and G-CSF is administered as in arm I
Within 4-6 weeks of day 0 of high-dose chemotherapy patients with estrogen andor progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years
Quality of life is assessed before therapy at 30 days after high-dose chemotherapy and at 6 and 12 months
Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| U01CA063265 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-IRB-98096 | None | None | None |
| CHNMC-PHII-18 | None | None | None |
| NCI-H99-0038 | None | None | None |
| CDR0000067305 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |