Phase I Trial of Paclitaxel, Cisplatin, and Irinotecan in Patients With Advanced Solid Tumor Malignancies
cisplatin
+ irinotecan hydrochloride
+ paclitaxel
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel when combined with cisplatin and irinotecan in patients with locally advanced or metastatic solid tumors. II. Determine the dose limiting toxicity of paclitaxel when combined with cisplatin and irinotecan in this patient population. III. Establish the recommended phase II dose for this regimen in this patient population. IV. Assess the antitumor activity of this regimen in selected solid tumor malignancies. OUTLINE: This is a dose escalation study of paclitaxel. All patients receive paclitaxel IV over 1 hour, then cisplatin IV over 30 minutes, followed by irinotecan IV over 30 minutes weekly for 4 weeks on days 1, 8, 15, and 22. Treatment is repeated every six weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel. If 2 or more patients experience dose limiting toxicity (DLT) at a particular dose level, escalation ceases and the maximum tolerated dose (MTD) is defined as the previous dose level. Patients are followed until death. PROJECTED ACCRUAL: Approximately 12-27 patients will be accrued for this study within 6-9 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.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.Critères
DISEASE CHARACTERISTICS: Histologically proven locally advanced (unresectable or recurrent) or metastatic solid tumor No bone metastases, abnormal radionuclide bone scan or pleural effusions as the sole indicators of disease No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) No Gilbert's Disease Renal: Creatinine no greater than 1.5 mg/dL Serum calcium less than 12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable angina No active angina No New York Heart Association class III or IV heart disease No uncontrolled asymptomatic congestive cardiac failure At least 6 months since any myocardial infarction Pulmonary: No interstitial pulmonary fibrosis Other: No history of seizure disorder and receiving phenytoin, phenobarbital, or other antiepileptic medication No active or uncontrolled infection No uncontrolled diabetes mellitus Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior chemotherapy regimen allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior mantle, hemibody, pelvic, or lumbar spine irradiation 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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps