- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00003768
Combretastatin A4 Phosphate in Treating Patients With Advanced Solid Tumors
A Phase I Pharmacokinetic Study of Single Dose Intravenous CA4P in Patients With Advanced Cancer
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 combretastatin A4 phosphate in treating patients who have advanced solid tumors that have not responded to previous therapy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES: I. Determine the maximum tolerated dose of combretastatin A4 phosphate when administered at single doses every 21 days in patients with advanced solid tumors. II. Determine both the toxicity and dose limiting toxicity of this regimen in these patients. III. Determine the plasma and urine pharmacokinetics of combretastatin A4 and combretastatin A4 phosphate. IV. Gather preliminary data regarding possible antitumor effects in those patients with measurable disease.
OUTLINE: This is an open label, dose escalation study. Patients receive combretastatin A4 phosphate IV over 10-60 minutes. Treatment repeats every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of combretastatin A4 phosphate 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 are followed at 3 weeks.
PROJECTED ACCRUAL: A maximum of 21 patients will be accrued for this study.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Ohio
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Cleveland, Ohio, États-Unis, 44106-5065
- Ireland Cancer Center
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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 proven advanced solid tumors that have failed standard therapy or for which no curative therapy exists No leukemia, lymphoma, or multiple myeloma No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal SGOT/SGPT no greater than 3 times upper limit of normal (ULN) PT/PTT less than ULN OR International normalized ratio (INR) less than 1.1 Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clear evidence of acute ischemic heart disease on EKG No history of myocardial infarction within past 6 months No history of angina No peripheral vascular disorder Neurologic: No active seizure disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of hematemesis, melena, or hematochezia No history of inflammatory bowel disease, autoimmune disease, or bleeding disorders No Type I diabetes mellitus or Type II diabetes with peripheral vascular disorders No active infections or any serious concurrent systemic disorders incompatible with study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 6 weeks since prior major surgery Other: At least 4 weeks since any other prior investigational agent No concurrent anticonvulsant therapy No concurrent aspirin greater than 100 mg per day, heparin, or nonsteroidal antiinflammatory medication No concurrent calcium channel blockers, antiarrhythmias, or anti-angina therapy Concurrent beta-blocking agents for hypertension or anxiety allowed
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Scot C. Remick, MD, Case Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
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
- ILEX1Y98
- CWRU-ILEX-1Y98
- ILEX-1Y98
- ILEX-CA4P101-A3
- NCI-G99-1502
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