Paclitaxel With or Without Trastuzumab Following Peripheral Stem Cell Transplantation in Treating Patients With Refractory Stage IV Breast Cancer
Treatment of Refractory Stage IV Metastatic Breast Cancer With Weekly Paclitaxel or Weekly Paclitaxel and Herceptin Following Autologous/Syngeneic Stem Cell Transplant
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Paclitaxel may stop the growth of breast cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to compare the effectiveness of paclitaxel with or without trastuzumab following peripheral stem cell transplantation in treating patients who have refractory stage IV breast cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES: I. Determine the toxicity of paclitaxel with or without trastuzumab following high dose chemotherapy with autologous or syngeneic peripheral blood stem cell transplantation in patients with stage IV breast cancer. II. Assess the overall survival of these patients.
OUTLINE: Patients begin study treatment within 50-150 days after autologous or syngeneic peripheral blood stem cell transplantation. Patients are stratified according to overexpression of HER2-Neu (yes vs no), which determines the type of therapy. Arm I (overexpression of HER2-Neu): Patients receive paclitaxel IV over 60 minutes followed by the initial loading dose of trastuzumab IV over 90 minutes. If the loading dose is tolerated well, then patients receive maintenance trastuzumab IV over 30 minutes. Treatment with paclitaxel followed by maintenance trastuzumab repeats once every week for 12 weeks in the absence of disease progression or unacceptable toxicity. Arm II (no overexpression of Her2-Neu): Patients receive paclitaxel IV over 60 minutes once every week for 12 weeks. Patients with hormone receptor positive disease also receive antihormonal therapy (tamoxifen or anastrozole) as clinically indicated. Patients with isolated metastasis such as a single bone lesion may receive radiotherapy to that site after completion of study treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study over 2-3 years.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Washington
-
Seattle, Washington, États-Unis, 98109
- Fred Hutchinson Cancer Research Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS: Refractory stage IV breast cancer Received high dose chemotherapy (HDC) with autologous or syngeneic peripheral blood stem cell transplantation (PBSCT) OR Stage IV breast cancer Failed to achieve complete response to HDC with autologous or syngeneic PBSCT at initial restaging following HDC No enrollment on protocol FHCRC-976, unless evidence of no response or progressive disease at initial restaging following transplantation Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 (untransfused) Absolute neutrophil count greater than 1,000/mm3 (without filgrastim (G-CSF) support) Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF greater than 40% No poorly controlled arrhythmias No prior coronary artery disease No congestive heart failure within last year No myocardial infarction within past 2 years Other: No active infection No grade 3 regimen related toxicity according to Bearman model No allergy to paclitaxel, trastuzumab, or benzyl alcohol No grade 3 peripheral neuropathy with last chemotherapy HIV negative Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Concurrent antihormonal therapy (tamoxifen or anastrozole) allowed as clinically indicated for hormone receptor positive disease Radiotherapy: Not specified Surgery: Not specified
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Tumeurs
- Tumeurs par site
- Maladies du sein
- Tumeurs mammaires
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Agents antinéoplasiques immunologiques
- Paclitaxel
- Trastuzumab
Autres numéros d'identification d'étude
- 1338.00
- FHCRC-1338.00
- GENENTECH-FHCRC-1338.00
- NCI-G99-1557
- CDR0000067230 (Identificateur de registre: PDQ)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .