Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
PHASE I TRIAL OF IRINOTECAN AND TOMUDEX IN COMBINATION ON AN EVERY THREE WEEK SCHEDULE
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating patients with advanced solid tumors.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES: I. Determine the maximum tolerated dose of ICI D1694 (TDX) when given with irinotecan (CPT-11) every 3 weeks in patients with advanced solid malignancies. II. Describe the pharmacokinetics of TDX and CPT-11 when given in combination. III. Investigate the relationship between topoisomerase I expression in peripheral mononuclear cells and myelosuppression and/or gastrointestinal toxicity. IV. Investigate the effect of CPT-11 on thymidylate synthase expression in tumor.
OUTLINE: This is a dose-escalating study to determine the maximum tolerated dose (MTD) of ICI D1694 (TDX) given in combination with irinotecan. Irinotecan is given intravenously on day 1 and ICI D1694 intravenously on day 2. Treatment is repeated every 3 weeks until disease progression or unacceptable toxicity intervenes. Cohorts of 3-6 patients receive escalated doses of TDX until the MTD is defined; an additional 10-12 patients will be entered at the MTD to confirm this as a recommended phase II dose.
PROJECTED ACCRUAL: 30-35 patients will be entered.
Type d'étude
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania 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 confirmed solid tumor for which no effective therapy exists Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 5 times normal Renal: Creatinine no greater than 1.5 mg/dL Metabolic: Glucose no greater than 200 mg/dL Electrolytes within 10% normal Other: No active infection that contraindicates entry No significant medical problem that contraindicates entry Effective contraception required of fertile patients Able and willing to participate in pharmacokinetic sampling
PRIOR CONCURRENT THERAPY: At least 3 weeks since chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered At least 3 weeks since radiotherapy and recovered
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Peter J. O'Dwyer, MD, BCh, Abramson Cancer Center of the University of Pennsylvania
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Réel)
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
- CDR0000065242
- UPCC-T96-0063
- JMC-T96-0063
- NCI-T96-0063O
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