HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER
OBJECTIVES: I. Investigate the curative potential of high-dose cyclophosphamide, etoposide,
and carboplatin followed by autologous stem cell rescue in women with breast cancer
considered incurable by conventional therapy. II. Observe the overall response rate,
survival rate, and toxicity associated with this regimen.
OUTLINE: Prior to therapy, patients undergo collection of peripheral blood stem cells (PBSC)
on another protocol; patients with marrow involvement undergo PBSC harvest only, while all
others may also undergo bone marrow harvest. All patients receive cyclophosphamide,
etoposide, and carboplatin over 4 consecutive days, followed 3 days later by PBSC or bone
marrow and granulocyte colony-stimulating factor. Patients are followed for duration of
remission and survival.
PROJECTED ACCRUAL: 100-200 patients will be entered.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Thomas R. Klumpp, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000078064
NCT00002509
November 1991
December 2003
Name | Location |
---|---|
Temple University Cancer Center | Philadelphia, Pennsylvania 19140 |