Phase I Study of S-1 Combined with Irinotecan (CPT-11) in Patients with Advanced Gastric Cancer (OGSG 0002)

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Phase I study of S-1 combined with irinotecan (CPT-11) in patients with advanced gastric cancer (OGSG 0002).

OBJECTIVE A dose-escalation study of irinotecan (CPT-11) combined with S-1, a novel oral fluoropyrimidine, was performed to determine the maximum-tolerated dose (MTD), recommended dose (RD) and dose-limiting toxicities (DLTs) in advanced gastric cancer. METHODS S-1 was administered orally at 80 mg/m(2)/day for 21 consecutive days followed by a 2 week rest. CPT-11 was given intravenously on da...

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Phase I-II study of irinotecan combined with mitomycin-C in patients with advanced gastric cancer.

BACKGROUND Irinotecan (CPT-11) shows synergism with mitomycin-C (MMC) in a preclinical setting. The goals of this study were to determine the maximum tolerated dose (MTD), the dose limiting toxicity, the recommended dose (RD), and preliminary anti-tumor activity in a combined CPT-11 and MMC treatment of advanced gastric cancer. PATIENTS AND METHODS The study was designed to evaluate escalated...

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Irinotecan hydrochloride (CPT-11) in dialysis patients with gastrointestinal cancer.

We investigated changes in drug disposition and toxicities with CPT-11 in 15 dialysis patients with gastrointestinal cancers to clarify whether CPT-11 could be administered safely in such patients. For comparison, the same parameters were also investigated in 10 cancer patients not undergoing dialysis. Items investigated included (1) plasma concentrations of SN-38, SN-38G and CPT-11 at 0, 1, 12...

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Phase II Study of Irinotecan plus S-1 in Treatment of Advanced Gastric Cancer

Objective: The efficacy and safety of irinotecan hydrochloride (CPT-11) plus oral fluoropyrimidine S-1 combination therapy in patients with previously untreated advanced gastric cancer was evaluated. Methods: The regimen comprised CPT-11 plus S-1: CPT-11, 60 mg/m (days 1, 15); S-1, 40 60 mg/body twice daily (days 1 21) followed by a 1-week rest, every 4 weeks. Primary endpoint was response rate...

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Phase II study of combination therapy with S-1 and irinotecan in patients with advanced colorectal cancer.

BACKGROUND A combination of irinotecan with continuous intravenous infusions of 5-fluorouracil (5-FU) and leucovorin (LV) is often used to treat advanced colorectal cancer. However, recent concerns about safety and convenience have prompted the development of new oral fluoropyrimidine derivatives and improved regimens. This phase II study evaluated the efficacy and safety of the oral fluoropyri...

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ژورنال

عنوان ژورنال: Japanese Journal of Clinical Oncology

سال: 2005

ISSN: 1465-3621,0368-2811

DOI: 10.1093/jjco/hyi148