High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Poor-Prognosis Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with combinations of drugs may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation or autologous bone marrow transplantation in women with stage II breast cancer with eight or more positive axillary lymph nodes and in women with stage III or metastatic breast cancer.
|Breast Cancer||Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: mesna Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||November 1991|
|Study Completion Date:||December 2003|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002509
|United States, Pennsylvania|
|Temple University Cancer Center|
|Philadelphia, Pennsylvania, United States, 19140|
|Study Chair:||Thomas R. Klumpp, MD||Fox Chase Cancer Center|