Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

September 26, 1995

Primary Completion Date

March 9, 2006

Study Completion Date

March 9, 2006

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Filgrastim (G-CSF)

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.

DRUG

Carmustine

Upon recovery of hematopoiesis patients then receive high by vein (IV) doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days

DRUG

Cisplatin

As part of CVP chemotherapy treatment by vein (IV) on days 1-3.

DRUG

Cyclophosphamide (CTX)

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.

DRUG

Etoposide

CVP chemotherapy treatment IV on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin.

DRUG

Thiotepa

Upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Infusion of stem cells on Day 0.

Trial Locations (1)

77030-4009

University of Texas - MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT00002836 - Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer | Biotech Hunter | Biotech Hunter