Multiple Cycles of High Dose Chemotherapy Supported With Filgrastim and Peripheral Blood Progenitor Cells in Patients With Metastatic Breast Cancer
18 Years
65 Years
Both
Breast Cancer
Trial Information
Multiple Cycles of High Dose Chemotherapy Supported With Filgrastim and Peripheral Blood Progenitor Cells in Patients With Metastatic Breast Cancer
OBJECTIVES: I. Determine the effects on 2 year progression-free survival of a regimen
consisting of cyclophosphamide, paclitaxel, and filgrastim (G-CSF) to mobilize peripheral
blood progenitor cells (PBPCs), followed by 2 courses of carboplatin and paclitaxel followed
by 1 course of melphalan, each supported with PBPCs and G-CSF, in patients with recurrent or
refractory, advanced breast cancer. II. Evaluate the feasibility of administering multiple
courses of high dose chemotherapy in an outpatient setting for these patients. III. Evaluate
the rate of complete response to the high dose therapy in these patients.
OUTLINE: This is a multicenter study. Patients receive mobilization therapy consisting of
cyclophosphamide IV over 1 hour followed by paclitaxel IV over 3 hours, then filgrastim
(G-CSF) beginning 24 hours following completion of paclitaxel and continuing through the
last day of leukapheresis. Leukapheresis continues until an adequate number of CD34+ cells
is collected. Following cell count recovery, patients receive 3 courses of high-dose
chemotherapy: 2 courses of paclitaxel IV over 3 hours followed by carboplatin IV over 1
hour, with the first course generally within 21 days after completion of leukapheresis and
the second course 21-35 days after the first; then 1 course of melphalan IV infused over 30
minutes 21-35 days after the previous carboplatin dose. Each course of chemotherapy is
followed 24-48 hours later by the infusion of G-CSF-mobilized peripheral blood progenitor
cells and G-CSF. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 96 evaluable patients will be accrued for this study over 3
years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory, metastatic breast
cancer Patients previously treated for metastatic disease must show response to last
standard dose chemotherapy regimen within 60 days of study entry OR Patients with no
evidence of disease (e.g., resected skin lesions) must show no evidence of progression or
bone disease No CNS metastases No disease progression following prior platinum or
paclitaxel based regimens Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Not specified Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 90,000/mm3 No prior inability
to mobilize adequate peripheral blood progenitor cells for high dose therapy Hepatic:
Bilirubin no greater than 1.8 mg/dL Transaminases stable and no greater than 3 times upper
limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF within
normal limits No significant cardiovascular disease No coronary artery disease No
arrhythmias No congestive heart failure Other: Not pregnant or nursing Negative pregnancy
test required of fertile women Effective contraception required of fertile patients Not
HIV positive No nonmalignant disease precluding protocol treatment No sensitivity to E.
coli-derived drug preparations No prior participation in this study No greater than grade
I neurotoxicity
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cellular support for high dose
chemotherapy Chemotherapy: See Disease Characteristics No more than 6 prior courses of
chemotherapy for metastatic disease At least 3 weeks since prior chemotherapy and
recovered No prior high dose chemotherapy with cellular support Endocrine therapy: No
concurrent steroid therapy Concurrent hormonal therapy allowed Radiotherapy: At least 3
weeks since prior radiotherapy and recovered No prior extensive pelvic radiation Surgery:
Not specified Other: Recovered from acute toxic effects of any prior therapy No concurrent
anticoagulation therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Thomas C. Shea, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
LCCC 9727
NCT ID:
NCT00003392
Start Date:
September 1997
Completion Date:
January 2003
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Temple University Cancer Center | Philadelphia, Pennsylvania 19140 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
| New York Medical College | Valhalla, New York 10595 |
| Scripps Clinic | La Jolla, California 92037 |
| Methodist Hospital-Central Unit | Memphis, Tennessee 38104 |
| University of California San Diego | La Jolla, California 92093 |
| Bone Marrow Stem Cell Transplant Institute of Florida | Fort Lauderdale, Florida 33313 |
| Stem Cell Sciences | New York, New York 10016 |
| University of Rochester School of Medicine | Rochester, New York 14642 |
