PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
filgrastim
+ cisplatin
+ ifosfamide
Maladies génito-urinaires+17
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1994
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin. Determine the efficacy of this regimen as salvage therapy in these patients. OUTLINE: This is a dose escalation study of paclitaxel. Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the MTD. After completion of chemotherapy, some patients may undergo resection of residual masses. PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 2 years.
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.43 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.À partir de 15 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 germ cell tumor that is resistant to a platinum-based chemotherapy regimen Active disease meeting 1 of the following conditions: Measurable or evaluable disease Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin) Unresectable residual disease after postchemotherapy surgery Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following: No more than 1 prior regimen or 6 prior courses of cisplatin Testis or ovarian germ cell primary site Prior CR to cisplatin therapy Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator Cardiovascular: If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry Other: No active infection not well controlled on antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior paclitaxel or ifosfamide At least 3 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Recovered from recent surgery
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps