Phase I/II study of CPT-11 plus UFT in patients with advanced/recurrent colorectal cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG): Protocol 0102
Autor: | Hiroyuki Narahara, Naohiro Tomita, Hideyuki Ishida, Mutsumi Fukunaga, Ryu Ishihara, Noriya Uedo, Shu Okamura, Hiroshi Furukawa, Masahiro Gotoh, Hiroya Takiuchi |
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Rok vydání: | 2007 |
Předmět: |
Adult
Cancer Research medicine.medical_specialty Adolescent Colorectal cancer medicine.medical_treatment Phases of clinical research Administration Oral Neutropenia Adenocarcinoma Irinotecan Gastroenterology Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Radiology Nuclear Medicine and imaging Infusions Intravenous Uracil Aged Tegafur Chemotherapy business.industry Combination chemotherapy General Medicine Middle Aged medicine.disease Chemotherapy regimen Antineoplastic Agents Phytogenic Surgery Regimen Oncology Camptothecin Neoplasm Recurrence Local business Colorectal Neoplasms medicine.drug |
Zdroj: | Japanese journal of clinical oncology. 37(7) |
ISSN: | 1465-3621 |
Popis: | Objective: The primary objective of this study was to explore the efficacy and safety of combined chemotherapy with CPT-11 and UFT in patients with advanced/metastatic colorectal cancer. Methods: Twenty-two patients with metastatic colorectal cancer were enrolled in the phase I trial and 35 patients (including eight patients treated at level 4 during phase I) were evaluated in the phase II trial. Treatment consisted of two 35-day cycles of combination chemotherapy with CPT-11 and UFT. During phase I, CPT-11 was administered on days 1 and 15 as an intravenous infusion over 90 min at four different dose levels, starting from a dose of 80 mg/ m 2 (level 1). During phase II, the dose of CPT-11 was fixed at 150 mg/m 2 based on the results of the phase I study. UFT was administered orally at a fixed dose of 300 mg/m 2 on days 1‐28, followed by a 1-week drug holiday, during each course (35 days). Results: The maximum tolerated dose (MTD) of CPT-11 was determined to be 150 mg/m 2 during the phase I trial. The major toxicities detected during phase II in 35 patients receiving CPT-11 at this recommended dose were grade 3/4 neutropenia in nine patients (25.7%) and grade 3/4 anorexia in six patients (11.4%). No severe adverse events occurred. The overall response rate and the median overall survival time was 22.9% (8/35) and 23.9 months for all patients, respectively. For pre-treated patients they were 26.3% (5/19) and 25.1 months, respectively. Conclusion: This combination of CPT-11 and UFT is considered to be both feasible and relatively safe. The response rate of the patients receiving CPT-11 at a dose of 150 mg/m 2 was comparable to that reported previously for 5-FU-based regimens coupled with CPT-11, and this regimen can probably be beneficial for patients with pre-treated advanced colorectal cancer on an outpatient basis. |
Databáze: | OpenAIRE |
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