Phase II Trial of Weekly Intravenous Gemcitabine With Continuous Infusion Fluorouracil in Patients With Metastatic Renal Cell Cancer

• Published in: Journal of clinical oncology Vol. 18; no. 12; pp. 2419 - 2426
• Main Authors: RINI, B. I, VOGELZANG, N. J, DUMAS, M. C, WADE, J. L, TABER, D. A, STADLER, W. M
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 01.06.2000; Lippincott Williams & Wilkins
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Renal Cell - drug therapy; Carcinoma, Renal Cell - pathology; Chemotherapy; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease-Free Survival; Drug Administration Schedule; Female; Fluorouracil - administration & dosage; Humans; Infusions, Intravenous; Kidney Neoplasms - drug therapy; Kidney Neoplasms - pathology; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Treatment Outcome; Kidney disease; Antineoplastic agent; Human; Drug combination; Urinary system disease; Carcinoma; Intravenous administration; Gemcitabine; Fluoropyrimidine derivatives; Malignant tumor; Kidney; Continuous process; Chemotherapy; Treatment; Weekly; Perfusion; Phase I trial; Pyrimidine derivatives; Metastatic; Fluorine Organic compounds; Pyrimidine nucleoside; Fluorouracil
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2000.18.12.2419

To determine the clinical response rate of the combination of weekly intravenous (IV) gemcitabine with continuous infusion fluorouracil (5-FU) in patients with metastatic renal cell carcinoma (RCC). Between June 1998 and February 1999, 41 patients with metastatic RCC were enrolled onto this multi-institutional phase II study of gemcitabine 600 mg/m(2) over 30 minutes on days 1, 8, and 15 and 5-FU 150 mg/m(2)/d via continuous IV infusion through a permanent catheter on days 1 to 21 of a 28-day cycle. Patients had a Cancer and Leukemia Group B performance status of 0 or 1, with a median time since diagnosis of metastatic disease of 10 months (range, 0 to 129 months). Thirty-three patients (80%) had multiple metastatic sites, and 34 patients (83%) had prior chemotherapy or immunotherapy. Of the 39 assessable patients, there were no complete responses but seven partial responses (objective response rate = 17%; 95% confidence interval, 8% to 34%). Five minor responses (25% to 50% decreased tumor size) were also observed. The duration of response for the seven partial responders was 2, 3, 7, 8, 10, 11, and 14 months. Median progression-free survival for the gemcitabine/5-FU group was 28.7 weeks versus 8 weeks for a similar cohort of patients treated on previous phase II studies at the University of Chicago (P =.008). The regimen was well tolerated, with fatigue, mucositis, nausea/vomiting, and grade 2 hematologic toxicities being most common. Weekly gemcitabine with continuous infusion 5-FU is an active combination in patients with metastatic RCC. Therapy was well tolerated and produced an improvement in progression-free survival over historical controls.