Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003050
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Paclitaxel in Treating Patients With Stage IIB or Stage III Breast Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Weekly Paclitaxel During Radiation Therapy for Locally Advanced Breat Cancer
Status:
COMPLETED
Status Verified Date:
2014-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients with stage IIB or stage III breast cancer
PURPOSE Phase II trial to study the effectiveness of radiation therapy plus paclitaxel in treating patients with stage IIB or stage III breast cancer
Detailed Description:
OBJECTIVES I Evaluate the safety and feasibility of twice a week paclitaxel and radiation therapy in patients with locally advanced breast cancer II Determine the pathological effects of paclitaxel and radiation in locally advanced breast cancer
OUTLINE This is a nonrandomized dual institution study Patients receive paclitaxel IV over 1 hour twice a week for a total of 8 weeks This is started within 1 week of a tumor biopsy Patients receive radiotherapy 5 daysweek for 50 weeks within 1 week of the first paclitaxel dose Operable patients who have progressive disease with the above therapy undergo a modified radical mastectomy MRM then receive 4 courses of doxorubicin IV and cyclophosphamide IV administered once every 21 days Inoperable patients receive this same chemotherapy regimen then are reevaluated for surgery Patients who have stable disease or who respond to the paclitaxelradiation regimen undergo a MRM then receive 4 courses of doxorubicin IV and paclitaxel IV over 3 hours once every 21 days All patients with hormone receptor positive tumors receive tamoxifen for 5 years after all other therapy is completed
PROJECTED ACCRUAL A total of 40 patients 20 patients per institution will be accrued over 18- 24 months
OUTLINE This is a nonrandomized dual institution study Patients receive paclitaxel IV over 1 hour twice a week for a total of 8 weeks This is started within 1 week of a tumor biopsy Patients receive radiotherapy 5 daysweek for 50 weeks within 1 week of the first paclitaxel dose Operable patients who have progressive disease with the above therapy undergo a modified radical mastectomy MRM then receive 4 courses of doxorubicin IV and cyclophosphamide IV administered once every 21 days Inoperable patients receive this same chemotherapy regimen then are reevaluated for surgery Patients who have stable disease or who respond to the paclitaxelradiation regimen undergo a MRM then receive 4 courses of doxorubicin IV and paclitaxel IV over 3 hours once every 21 days All patients with hormone receptor positive tumors receive tamoxifen for 5 years after all other therapy is completed
PROJECTED ACCRUAL A total of 40 patients 20 patients per institution will be accrued over 18- 24 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 |
|---|---|---|---|
| NCI-G97-1304 | None | None | None |
| LAC-USC-1B972 | None | None | None |