Phase I Evaluation of Topotecan in Combination With Paclitaxel and Carboplatin
filgrastim
+ carboplatin
+ paclitaxel
Adénopathie+41
+ Maladie chronique
+ Infections par virus ADN
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the maximum tolerated doses of combined topotecan, paclitaxel, and carboplatin (TOPO/TAX/CBDCA) with or without filgrastim (G-CSF) in patients with advanced solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether TAX/CBDCA will affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day 3. IV. Describe any clinical responses observed in these patients. OUTLINE: This is a dose escalation study of the combination topotecan/paclitaxel/carboplatin. Patients are stratified according to prior chemotherapy and radiotherapy (yes vs no). Part I: Patients receive topotecan IV on days 1-3 and paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes, on day 1. Part II: Patients receive topotecan, paclitaxel, and carboplatin as in part I, plus filgrastim (G-CSF) on days 6-19. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of topotecan/paclitaxel/carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 4 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.17 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 18 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 advanced solid tumor or lymphoma that is refractory to standard therapy or for which no standard therapy exists or for which the drugs used in this regimen constitute standard therapy Brain metastasis eligible provided: Evidence of neurologic improvement or normalization No evidence of radiographic progression after appropriate therapy Steroid dose stable (if given) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Greater than 3 months Hematopoietic: Absolute granulocyte count at least 2,000/mm2 Platelet count at least 100,000/mm2 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within 6 months No history of congestive heart failure No uncontrolled angina No uncontrolled arrhythmia Other: No concurrent medical illness or active infection that would render treatment unsafe Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior topotecan, paclitaxel, and carboplatin allowed if progression observed greater than 3 months after last dose No prior mitomycin or nitrosoureas No more than 1 prior chemotherapy regimen At least 4 weeks since chemotherapy and recovered (alopecia allowed) Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 25% of bone marrow At least 4 weeks since radiotherapy and recovered (alopecia allowed) Surgery: Not specified
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