High-Dose Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of high-dose chemotherapy and peripheral
      stem cell transplantation in treating patients with recurrent or refractory metastatic breast
      cancer.
    

Detailed description: 
      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.
    

Intervention name(s): filgrastim; carboplatin; cyclophosphamide; melphalan; paclitaxel; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): 10 mcg/kg/d, day 2 through last day of leukapheresis; 18 AUC IV, approximately days 21, 42; 4 gm/m2 IV, day 1; 140 mg/m2 IV , approximately day 63; 170 mg/m2 IV day 1
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer