Leucovorin, 5-fluorouracil, and gemcitabine: A phase I study

التفاصيل البيبلوغرافية
العنوان: Leucovorin, 5-fluorouracil, and gemcitabine: A phase I study
المؤلفون: John D. Roberts, Elizabeth Poplin, Eric J. Rubin, Marybeth Tombs, Steven Grant
المصدر: Investigational New Drugs. 17:57-61
بيانات النشر: Springer Science and Business Media LLC, 1999.
سنة النشر: 1999
مصطلحات موضوعية: Adult, Male, Antimetabolites, Antineoplastic, medicine.medical_specialty, Time Factors, medicine.drug_class, medicine.medical_treatment, Leucovorin, Deoxycytidine, Antimetabolite, Gastroenterology, Thymidylate synthase, Breast cancer, Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Carcinoma, Humans, Pharmacology (medical), Aged, Pharmacology, Chemotherapy, Performance status, biology, Chemistry, Middle Aged, medicine.disease, Gemcitabine, Treatment Outcome, Endocrinology, Oncology, Fluorouracil, biology.protein, Female, medicine.drug
الوصف: Gemcitabine is a chemotherapy agent with efficacy in the treatment of lung, pancreas, bladder and breast cancer. It inhibits DNA synthesis by interfering with cytidine triphosphate production and also inhibits the activity of ribonucleotide reductase. Gemcitabine may potentiate fluorouracil's inhibition of thymidylate synthase. This inhibition would be expected to be sequence dependent, occurring only if gemcitabine were administered following fluorouracil (5FU). The combination of leucovorin, 5-FU, and gemcitabine was assessed in this phase I trial. Eligibility requirements included refractory solid tumor malignancy; adequate hematologic, renal and hepatic reserve; no prior therapy with the combination of leucovorin and 5FU, or with gemcitabine; ECOG performance status 0-2, and signed informed consent. Eleven men and nine women were eligible. The median age was 52.5 years and the median performance status was 1. All but three patients had prior chemotherapy. The starting doses were leucovorin 20 mg/m2, 5FU 255 mg/m2 and gemcitabine 600 mg/m2. 5FU and gemcitabine were escalated in tandem to 340 mg/m2 and 800 mg/m2 and thereafter to 425 mg/m2 and 1000 mg/m2, respectively. Gemcitabine administration always followed that of 5FU by 30 minutes. The median number of cycles was 2 (range 1-32). Two patients at the starting dose had disease progression within the first cycle with one death on day 28. One patient with cholangiocarcinoma had a partial response and remained on study for 40 months. There were no other responses. The maximum tolerated dose is leucovorin 20 mg/m2, 5FU 340 mg/m2, and gemcitabine 800 mg/m2. The impact of drug sequence remains undetermined.
تدمد: 1573-0646
0167-6997
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::20c9e20197e5083bbf1359f97d673bf6Test
https://doi.org/10.1023/a:1006239200772Test
حقوق: CLOSED
رقم الانضمام: edsair.doi.dedup.....20c9e20197e5083bbf1359f97d673bf6
قاعدة البيانات: OpenAIRE