Clinical trial NCT00002836: Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer
Official title: A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients
Conditions: Breast Cancer
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 person's immune system recover from the side effects of chemotherapy. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus filgrastim with filgrastim alone in treating women undergoing peripheral stem cell transplantation for stage II, stage III, or metastatic breast cancer.
Interventions:
description: For group one (Filgrastim + Chemotherapy), given under the skin (SC) on day 4 every 12 hours until completion of apheresis; for group two (Filgrastim alone), beginning on day of reinfusion twice a day (bid) until white blood count (WBC) reaches a safe level.
name: Filgrastim (G-CSF)
other_name: G-CSF
Neupogen
type: Biological
description: Upon recovery of hematopoiesis patients then receive high by vein (IV) doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days
name: Carmustine
other_name: BCNU
BiCNU
type: Drug
description: As part of CVP chemotherapy treatment by vein (IV) on days 1-3.
name: Cisplatin
other_name: CDDP
Platinol
Platinol-AQ
type: Drug
description: In group one (Filgrastim + Chemotherapy) as part of CVP chemotherapy treatment by vein (IV) on days 1-3; and group two (Filgrastim alone), upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.
name: Cyclophosphamide (CTX)
other_name: Cytoxan
Neosar
type: Drug
description: CVP chemotherapy treatment IV on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin.
name: Etoposide
other_name: VePesid
type: Drug
description: Upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.
name: Thiotepa
type: Drug
description: Infusion of stem cells on Day 0.
name: Peripheral Blood Stem Cell Transplantation
other_name: PBSCT
Stem Cell Transplant
type: Procedure
Study arms:
design_group_title: Filgrastim + Chemotherapy
design_group_type: Experimental
design_group_title: Filgrastim
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 依托泊苷
lang: CN
name: Etoposide
lang: EN
name: エトポシド
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 卡莫司汀
lang: CN
name: Carmustine
lang: EN
name: カルムスチン
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
name: 塞替派
lang: CN
name: Thiotepa
lang: EN
name: チオテパ
lang: JP