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Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003927
  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. Amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine, and peripheral stem cell transplantation in treating patients who have stage II, stage III, or stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: amifostine trihydrate
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: filgrastim
Drug: paclitaxel
Procedure: peripheral blood stem cell transplantation
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Filgrastim    Paclitaxel    Amifostine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   15
Study Start Date:   March 1999

Detailed Description:

OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide, paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered with amifostine in this regimen in these patients. III. Assess the toxicity of this treatment regimen in this patient population.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day -2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years, then periodically thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.

  Eligibility
Ages Eligible for Study:   up to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven breast cancer including: Stage IV metastatic disease with current partial or complete response to prior induction chemotherapy High risk primary disease with less than 60% chance of progression free survival at 3 years Stage II tumors with 10 or more axillary node involvement Stage IIIA or IIIB tumors No bone marrow metastases No CNS metastases No more than 10 bone metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 59 and under Menopausal status: Not specified Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Neutrophil count greater than 2,000/mm3 Platelet count greater than 150,000/mm3 Hemoglobin greater than 9 g/dL (blood transfusions allowed) Hepatic: Bilirubin no greater than 1.2 mg/dL SGOT or SGPT less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.2 mg/dL Creatinine clearance at least 80 mL/min No prior hemorrhagic cystitis Cardiovascular: Ejection fraction at least 55% by MUGA No prior valvular heart disease or arrhythmia Pulmonary: DLCO at least 60% lower limit of predicted pCO2 no greater than 43 mmHg on room air pO2 greater than 85 mmHg on room air FEV 1 at least 2 liters Other: No other prior malignancy except basal or squamous cell skin cancer, or carcinoma in situ or stage I carcinoma of the cervix Not pregnant HIV negative Hepatitis B negative No prior history of disabling psychosocial disorder No other CNS dysfunction

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No more than 2 prior chemotherapy regimens for metastatic disease Prior total doxorubicin dose no greater than 180 mg/m2 Prior total paclitaxel dose no greater than 750 mg/m2 Endocrine therapy: At least 4 weeks since prior hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to the left chest wall No prior radiotherapy to greater than 20% of bone marrow (excluding syngeneic transplantation candidates) Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003927

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope    
      Duarte, California, United States, 91010-3000

Sponsors and Collaborators
Beckman Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     George Somlo, MD     Beckman Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067115, CHNMC-IRB-99002, ALZA-CHNMC-IRB-99002, NCI-G99-1527
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003927
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer  
stage IV breast cancer  
stage IIIA breast cancer  
stage IIIB breast cancer  

Study placed in the following topic categories:
Amifostine
Skin Diseases
Paclitaxel
Breast Neoplasms
Cyclophosphamide
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:
Radiation-Protective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on November 30, 2008




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