A Phase I, Maximum Tolerated Dose (MTD) Trial to Determine the Safety and Pharmacokinetics of Chronic Oral Administration of Farnesyl Transferase Inhibitor R115777 in Combination With Gemcitabine in Subjects With Advanced Incurable Cancer
gemcitabine hydrochloride
+ tipifarnib
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the maximum tolerated dose and dose limiting toxicities of tipifarnib in combination with gemcitabine in patients with advanced cancer. Investigate potential pharmacokinetic interactions between tipifarnib and gemcitabine in these patients. Determine the efficacy of this regimen in patients with measurable or evaluable disease. Evaluate the quality of life of these patients. OUTLINE: This is a dose-escalation study of tipifarnib. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral tipifarnib every 12 hours beginning on day 2. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which fewer than one third of the patients experience dose limiting toxicity. Quality of life is assessed before treatment, on day 22 of each course, and at the end of treatment. PROJECTED ACCRUAL: A maximum of 40 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.22 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: Pathologically proven advanced cancer for which no curative therapy exists PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin normal SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine normal Other: Unassisted oral or enteral intake sufficient to maintain a reasonable state of nutrition No concurrent medical condition that is likely to interfere with study participation No active visual disturbances that require intervention beyond corrective lenses Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior high dose chemotherapy with bone marrow or stem cell rescue No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy (except megestrol acetate) Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to 25% or more of bone marrow No concurrent radiotherapy (except palliative radiotherapy within the first 28 days of the study) Surgery: Not specified Other: At least 30 days since prior investigational therapy No concurrent investigational therapy
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
San Antonio Cancer Institute
San Antonio, United StatesOuvrir San Antonio Cancer Institute dans Google Maps