Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001338
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Prospective Randomized Phase III Trial of FLAC 5-Fluorouracil Leucovorin Adriamycin Cytoxan Chemotherapy With GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor Versus PIXY 321 in Advanced Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Randomized Phase III Trial of FLAC 5-Fluorouracil Leucovorin Adriamycin Cytoxan Chemotherapy With GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor Versus PIXY 321 in Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2000-04
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 is a prospective randomized Phase III trial of FLAC chemotherapy with GM-CSF versus PIXY321 in advanced breast cancer The primary endpoints of this study will be the duration of thrombocytopenia and the time to recovery of platelets to 50000microliters Other clinical endpoints will include the depth and duration of leukopenia neutropenia and anemia the platelet and RBC transfusion requirements and the number of documented instances of sepsis and hospitalizations for fever and neutropenia
Laboratory correlates will include the detailed evaluation of the effects on circulating hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents have on the bone marrow micro-environment
After 5 cycles of FLAC with GM-CSF versus PIXY321 patients will be treated with 5 cycles of 96 hour infusional taxol The goal of this part of the study will be to assess the toxicity and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy
Laboratory correlates will include the detailed evaluation of the effects on circulating hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents have on the bone marrow micro-environment
After 5 cycles of FLAC with GM-CSF versus PIXY321 patients will be treated with 5 cycles of 96 hour infusional taxol The goal of this part of the study will be to assess the toxicity and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy
Detailed Description:
This is a prospective randomized Phase III trial of FLAC chemotherapy with GM-CSF versus PIXY321 in advanced breast cancer The primary endpoints of this study will be the duration of thrombocytopenia and the time to recovery of platelets to 50000microliters Other clinical endpoints will include the depth and duration of leukopenia neutropenia and anemia the platelet and RBC transfusion requirements and the number of documented instances of sepsis and hospitalizations for fever and neutropenia
Laboratory correlates will include the detailed evaluation of the effects on circulating hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents have on the bone marrow micro-environment
After 5 cycles of FLAC with GM-CSF versus PIXY321 patients will be treated with 5 cycles of 96 hour infusional taxol The goal of this part of the study will be to assess the toxicity and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy
Laboratory correlates will include the detailed evaluation of the effects on circulating hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents have on the bone marrow micro-environment
After 5 cycles of FLAC with GM-CSF versus PIXY321 patients will be treated with 5 cycles of 96 hour infusional taxol The goal of this part of the study will be to assess the toxicity and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy
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 |
|---|---|---|---|
| 93-C-0153 | None | None | None |