- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00045318
Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
A Phase I Study of DX-8951f (Exatecan Mesylate for Injection) in Patients With Renal Dysfunction
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of exatecan mesylate in treating patients who have advanced solid tumors and kidney dysfunction.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the maximum tolerated dose of exatecan mesylate in patients with advanced solid tumors and varying degrees of renal dysfunction.
- Determine the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
- Determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of this drug in these patients.
- Establish a model for dosing this drug in patients with impaired renal function.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to severity of renal dysfunction (normal vs mild vs moderate vs severe).
Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients in each renal dysfunction stratum receive escalating doses of exatecan mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients in the normal renal function stratum do not undergo dose escalation.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 45 patients (6 normal, 9 mild, 12 moderate, and 18 severe renal dysfunction) will be accrued for this study within 1.5 years.
Type d'étude
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095
- Jonsson Comprehensive Cancer Center, UCLA
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Texas
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Fort Sam Houston, Texas, États-Unis, 78234
- Brooke Army Medical Center
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San Antonio, Texas, États-Unis, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, États-Unis, 78229
- Cancer Therapy and Research Center
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San Antonio, Texas, États-Unis, 78229
- St. Luke's Lutheran Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists
Renal function as defined by the following parameters:
- Normal (creatinine clearance (CrCl) greater than 80 mL/min)
- Mild dysfunction (CrCl 50-80 mL/min)
- Moderate dysfunction (CrCl 30-50 mL/min)
- Severe dysfunction (CrCl less than 30 mL/min)
- End-stage renal disease (requiring dialysis)
- No symptomatic or active brain metastases (e.g., edema or progression on CT scan or MRI)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9.0 g/dL
Hepatic
- Bilirubin normal
- AST or ALT no greater than 2 times upper limit of normal
- Albumin at least 2.8 g/dL
Renal
- See Disease Characteristics
Cardiovascular
- No active congestive heart failure
- No uncontrolled angina
- No myocardial infarction within the past 6 months
Other
- No concurrent serious infection
- No other life-threatening illness
- No overt psychosis or mental disability or other incompetency that would preclude informed consent
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent anticancer biologic therapy
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered
- No prior exatecan mesylate
- No other concurrent anticancer chemotherapy
Endocrine therapy
- No concurrent anticancer hormonal therapy
- Concurrent megestrol for appetite stimulation allowed
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent anticancer radiotherapy
Surgery
- At least 4 weeks since prior major surgery and recovered
- No concurrent anticancer surgery
Other
- At least 4 weeks since prior investigational drugs including analgesics or antiemetics
- At least 1 week since prior grapefruit juice
- No other concurrent anticancer therapy
- No other investigational drugs during and for 4 weeks after study
- No concurrent grapefruit juice
- No other concurrent anticancer cytotoxic therapy
- Concurrent chronic hemodialysis or ambulatory peritoneal dialysis allowed
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Carolyn Britten, MD, Jonsson Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DAIICHI-8951A-PRT026
- UCLA-0201008
- CDR0000256866 (Identificateur de registre: PDQ (Physician Data Query))
- NCI-G02-2103
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur mésylate d'exatécan
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Bio-Thera SolutionsRecrutementTumeurs solides localement avancées/métastatiquesChine