Phase II Trial of @entity136 , UFT-E, XXXX Combination Chemotherapy in Advanced @entity788 .

@entity4181 @entity1 @entity788 @entity137 @entity390 @entity294 @entity391 @entity33 @entity1398 @entity158 @entity136
PURPOSE: To evaluate the efficacy and @entity137 of a @entity136 , UFT-E, @entity4181 combination chemotherapy in the treatment of advanced @entity788 . @entity1 AND METHODS: @entity1 <=70 years, with no prior chemotherapy and with bidimensionally measurable advanced @entity788 , ECOG performance status <=2, and adequate bone marrow, kidney, and liver function were eligible for this trial. Eligibility criteria for clinical benefit assessment were @entity158 with at least a daily analgesic consumption of two nonsteroidal anti-inflammatory drugs or a Karnofsky performance status between 50 and 70. Treatment consisted of 1,000 mg/m2 of @entity136 on days 1, 8 and 15, repeated every 4 weeks, with UFT-E administered orally 500 mg-700 mg by body surface area (BSA). @entity4181 was administered 45 mg/day orally. Dosages of UFT-E and @entity4181 were divided and administered three times per day from day 1 to day 21. After 7 days of rest, UFT-E and @entity4181 were administered repeatedly. RESULTS: Twenty-three @entity1 were enrolled between April 1999 to April 2000. Eighty two cycles (median, four cycles) were delivered to all @entity1 . The objective response rate was 15.8% in 19 assessable @entity1 and 13.0% in the intent-to-treat population. Twelve @entity1 (57.9%) displayed stable disease. Grade 3 or 4 @entity1398 occurred in 30.4% of @entity1 , @entity390 / @entity391 in 8.3%, @entity294 in 4.3%, and @entity33 in 4.3%. The median time to progression was 8 months. The median survival was 8 months in the assessable population and 6 months in the intent-to-treat population Clinical benefit was achieved in 11 (57.9%) of 19 assessable @entity1 . CONCLUSION: @entity136 , UFT-E, @entity4181 combination chemotherapy is a well-tolerated and safe regimen in cases of advanced @entity788 . Although the response rate is low, it shows a survival benefit and clinical benefit and deserves further evaluation in a phase III trial.
