Clinical Trial: Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.

Condition Treatment or Intervention Phase
stage IIIB breast cancer
inflammatory breast cancer
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: filgrastim
 Drug: melphalan
 Drug: mesna
 Drug: paclitaxel
 Drug: tamoxifen
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: conventional surgery
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: surgery
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Dose Intensive Chemotherapy and Stem Cell Rescue in Patients with Inflammatory Stage IIIB Breast Cancer

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients are stratified according to those who have had no more than 1 cycle of neoadjuvant chemotherapy (stratum 1) and those who have had more than 1 cycle of neoadjuvant chemotherapy and/or modified radical mastectomy (stratum 2).

Patients in stratum 1 receive doxorubicin IV over 96 hours on days 1-4, 15-19, and 29-32. Paclitaxel is infused over 96 hours on days 43-47 and 57-60. Filgrastim (G-CSF) is administered on days 5-10, 20-25, 33-38, 48-55, and 61-68, and beyond if the granulocyte count is less than 1000/mm^3. A modified radical mastectomy is performed between days 70 and 80. All stratum 1 and stratum 2 patients then receive paclitaxel IV for 96 hours on days 100-104, and cyclophosphamide IV on day 121. Filgrastim is administered at one dose on days 105-110 and days 122-127 and at a higher dose on days 110-116 and days 128-135. Stem cells are harvested from the patient on days 113-116 and days 132-135.

High-dose chemotherapy is then administered to all patients in the study. Course 1 starts with doxorubicin IV on days -7 to -3. Paclitaxel IV is administered for 24 hours on day -2. Filgrastim is administered by IV on day -1 and continued until the granulocyte count is greater than 1000/mm^3 for 3 days. Peripheral stem cells are reinfused on day 0. Course 2 starts 4-6 weeks after the start of course 1 with melphalan and cisplatin being infused on day -11. Filgrastim is administered IV on days -10 to -6. Melphalan and cisplatin are administered again on day -4. Stem cells are infused on day -3 and on day 0. Filgrastim is then administered until the granulocyte count is at least 1000/mm^3 for 3 days.

Radiation therapy is started 4-7 weeks after the beginning of course 2. Tamoxifen is started within 2 weeks of discharge following course 2 in patients with hormone receptor positive tumors.

Patients are followed every 3 months for two years and then annually for the next three years.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued, at a rate of about 15 per year.

Eligibility

Ages Eligible for Study:  up to  60 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin
  • Diagnosis within the past 6 months

PATIENT CHARACTERISTICS: Age:

  • 60 and under

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT or SGPT no greater than 1.5 times the upper limit of normal

Renal:

  • Creatinine less than 1.2 mg/dL
  • Creatinine clearance at least 80 mL/min
  • No history of hemorrhagic cystitis

Cardiovascular:

  • Left ventricular fraction at least 55% on MUGA scan
  • No previous valvular heart disease or arrhythmia

Pulmonary:

  • FEV_1 at least 60% predicted
  • Room air pO_2 greater than 85 mmHg
  • Room air pCO_2 no greater than 43 mmHg
  • DLCO at least 60% of the lower limit of predicted value

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • Stratum 1:
  • No more than one cycle of chemotherapy
  • Stratum 2:
  • No greater than 225 mg/m^2 doxorubicin and no greater than 250 mg/m^2 paclitaxel during previous chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

Surgery:


Location and Contact Information


California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
Clinical Trials Office - New Patient Services  800-826-4673    becomingapatient@coh.org 

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065672; CHNMC-96139; NCI-G97-1288; NCT00003042
Record last reviewed:  May 2004
Last Updated:  March 3, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003042
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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