Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma
filgrastim
+ cisplatin
+ cyclophosphamide
Breast Diseases+4
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: May 30, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the effectiveness of neoadjuvant dose intensive sequential chemotherapy, followed by surgical resection, adjuvant therapy, and tandem high dose chemotherapy and stem cell rescue in patients with inflammatory stage IIIB breast cancer. Determine the clinical and pathological remission rate (complete, partial, and overall) following neoadjuvant dose dependent sequential chemotherapy in patients with inflammatory stage IIIB breast cancer. Determine the relapse and survival rate of these patients with the above therapy. Determine the potential correlations between inflammatory features and hereditary background. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.41 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer No organic CNS dysfunction Not pregnant No known and potentially disabling psychosocial history Not positive for hepatitis B or HIV 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: No prior radiation to the left chest wall Surgery: Modified radical mastectomy allowed
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
City of Hope Comprehensive Cancer Center
Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google Maps