Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
gemcitabine hydrochloride
+ leucovorin calcium
+ tegafur-uracil
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer. Assess the toxicity of this combination regimen in this patient population. Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients. OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: A total of 36 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.36 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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 or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists Evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 8.0 mg/dL Hepatic: Bilirubin less than 2.0 mg/dL AST less than 3.0 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: No active infection requiring antibiotics Not pregnant or nursing Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil) and recovered No prior gemcitabine Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal contraception Radiotherapy: At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered Surgery: Prior major surgery allowed and recovered Other: No prior or concurrent antiviral nucleosides
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
Barbara Ann Karmanos Cancer Institute
Detroit, United StatesOuvrir Barbara Ann Karmanos Cancer Institute dans Google Maps