Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Five-year Overall Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Bilirubin less than 1.5 mg/dL
- •SGOT or SGPT no greater than 1.5 times the upper limit of normal
- •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
- •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
- •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
- •Modified radical mastectomy allowed
排除标准
- 未提供
研究组 & 干预措施
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: filgrastim (Biological)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: cisplatin (Drug)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: cyclophosphamide (Drug)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: doxorubicin hydrochloride (Drug)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: melphalan (Drug)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: mesna (Drug)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: paclitaxel (Drug)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: tamoxifen citrate (Drug)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: bone marrow ablation with stem cell support (Procedure)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: conventional surgery (Procedure)
1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: peripheral blood stem cell transplantation (Procedure)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: filgrastim (Biological)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: cisplatin (Drug)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: doxorubicin hydrochloride (Drug)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: melphalan (Drug)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: mesna (Drug)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: paclitaxel (Drug)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: tamoxifen citrate (Drug)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: bone marrow ablation with stem cell support (Procedure)
More than 1 cycle of neoadjuvant chemotherapy
Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.
干预措施: peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Five-year Overall Survival
时间窗: From date of mastectomy until date of death, 5 years post mastectomy.
Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause.
Three-year Relapse-free Survival
时间窗: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.
Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment.
次要结局
未报告次要终点