High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer
filgrastim
+ amifostine trihydrate
+ cyclophosphamide
Maladies du sein+3
+ Néoplasmes
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 18 mai 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.15 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 59 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Cancer Center and Beckman Research Institute, City of Hope
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