Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer - Article Alkeran; L-PAM
Clinical Trial: Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|stage IIIB breast cancer |
inflammatory breast cancer
| Drug: cisplatin |
Procedure: biological response modifier therapy
Procedure: bone marrow ablation with stem cell support
Procedure: colony-stimulating factor therapy
Procedure: conventional surgery
Procedure: cytokine therapy
Procedure: high-dose chemotherapy
Procedure: peripheral blood stem cell transplantation
|Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
- 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.
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.
Ages Eligible for Study: up to 60 Years, Genders Eligible for Study: Both
- 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
- Karnofsky 80-100%
- Not specified
- 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
- 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
- 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
- Not specified
- No prior radiation to the left chest wall
- Modified radical mastectomy allowed
Location and Contact Information
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
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
Cache Date: April 9, 2005