PHASE I TRIAL OF SEQUENTIAL TOMUDEX AND 5-FLUOROURACIL IN SUBJECTS WITH ADVANCED COLORECTAL CARCINOMA
fluorouracil
+ raltitrexed
Maladies du côlon+10
+ Maladies du système digestif
+ Néoplasmes du système digestif
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 1995
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Determine the maximum tolerated dose of raltitrexed when administered with fluorouracil in patients with advanced colorectal carcinoma. II. Determine the toxicity and safety of this regimen in these patients. III. Assess, in a preliminary manner, the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of raltitrexed. Patients receive raltitrexed IV over 15 minutes followed 24 hours later by fluorouracil IV. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of raltitrexed until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD. Patients are followed for 6 weeks. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months.
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.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.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or surgically unresectable colorectal carcinoma Measurable disease No CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal (5 times normal if known liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No severe concurrent infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen Prior fluorouracil-based regimen for advanced colorectal cancer allowed Prior fluorouracil with radiotherapy not considered therapy for advanced disease At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids except for antiemesis or as replacement therapy Radiotherapy: See Chemotherapy No prior radiotherapy to more than 30% of bone marrow Surgery: See Disease Characteristics At least 4 weeks since prior surgery unless fully recovered Other: No concurrent vitamin supplements containing folic acid No other concurrent anticancer 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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps