A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
irinotecan hydrochloride
Adénocarcinome+18
+ Carcinome
+ Infections par virus ADN
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors. Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population. OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 10-31 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.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 metastatic or unresectable high grade neuroendocrine tumor including: Small cell carcinoma Large cell neuroendocrine carcinoma Other high grade neuroendocrine carcinomas without specification to cell size No lung only involvement without any other primary site No primary small cell lung cancer with or without metastases Bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm High grade tumor indicated by at least one of the following: Growth pattern suggestive of neuroendocrine differentiation Mitotic rate greater than 15 mitoses per 10 hpf Presence of abundant necrosis Immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma No low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm^3 Granulocyte count at least 1,500/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No uncontrolled congestive heart failure requiring therapy Other: No active or uncontrolled infection HIV negative No psychiatric or other disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 2 prior chemotherapy regimens No prior camptothecins Endocrine therapy Not specified Radiotherapy Not specified 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