A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres (Polilactofate/Paclitaxel) in Patients With Ovarian Cancer
chemotherapy
+ paclitaxel
Maladies génito-urinaires+16
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2000
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the safety and tolerability of intraperitoneal administration of paclitaxel (Paclimer microspheres) in patients with recurrent or persistent ovarian or primary peritoneal carcinoma. II. Determine and confirm the maximum tolerated dose of this regimen in this patient population. III. Determine plasma paclitaxel concentrations at selected times after intraperitoneal administration of Paclimer microspheres in these patients. OUTLINE: This is a dose escalation study. Patients receive intraperitoneal paclitaxel (Paclimer microspheres) every 8 weeks for 2 courses. Cohorts of 1-3 patients receive escalating doses of intraperitoneal paclitaxel (Paclimer microspheres) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. Once the probable MTD is determined, an additional cohort of 8 patients is accrued to confirm the MTD. The MTD is confirmed as the dose level at which at least 6 of 8 patients demonstrate acceptable safety and tolerability. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.
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.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.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 21 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: Recurrent or persistent ovarian and/or primary peritoneal carcinoma Adequate potential intraperitoneal fluid distribution with no gross fluid loculations and adhesions that would significantly affect intraperitoneal drug distribution PATIENT CHARACTERISTICS: Age: 21 and over Performance status: GOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: No other sufficiently severe medical problems unrelated to malignancy that would preclude study compliance or cause exposure to undue risks No prior unmanageable reaction to paclitaxel PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea and mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to major bone marrow containing areas Surgery: Not specified Other: At least 1 month since other prior investigational agents
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 5 sites
Chao Family Comprehensive Cancer Center
Orange, United StatesOuvrir Chao Family Comprehensive Cancer Center dans Google MapsUniversity of Chicago Cancer Research Center
Chicago, United StatesIndiana University Cancer Center
Indianapolis, United StatesWashington University School of Medicine
St Louis, United States