Hepato-gastroenterology · 2007
Intraperitoneal paclitaxel: a possible impact of regional delivery for prevention of peritoneal carcinomatosis in patients with gastric carcinoma.
Клиническое исследование I фазыСтатьяНазвание и аннотация: Перевод в очереди
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Kodera Yasuhiro, Ito Yuichi, Ito Seiji, Ohashi Norifumi, Mochizuki Yoshinari, Yamamura Yoshitaka, Koike Masahiko, Fujiwara Michitaka, Nakanishi Hayao, Nakao Akimasa
Аннотация
BACKGROUND/AIMS: Peritoneal carcinomatosis is a common pattern of failure among gastric cancer patients. Adequate postoperative adjuvant chemotherapy could reduce the risk of this lethal recurrence.
METHODOLOGY: Intraperitoneal (IP) paclitaxel, a useful option for treatment of ovarian cancer, was tested in a phase I trial involving gastric carcinoma patients. The eligibility criteria included confirmed gastric carcinoma patients with uncontrollable ascites, Eastern Cooperative Oncology Group performance status < or = 2, adequate major organ functions, and clinical disease progression following prior treatment(s) with oral or intravenous anticancer drugs. The starting dose (Level 1) was 60 mg/m2 weekly for 3 weeks followed by a week of rest, and the treatment was to be continued for at least 2 cycles unless unacceptable toxicity occurred. Peritoneal and plasma samples were obtained 0 hour, 3 hours, 24 hours, and one week after the end of drug instillation for pharmacokinetic analysis
RESULTS: Of 4 patients enrolled, 3 were eligible and evaluable for toxicity. Three of the 4 patients failed to receive two cycles of treatment chiefly because of failure in the drug delivery, resulting in termination of the trial in the current form. Peak IP/plasma ratio of > 2000 was obtained at 3 hours after administration. Half-life of the drug ranged from 17.4 to 65.3 hours. Ascites diminished in 2 of 3 patients during the course of the treatment.
CONCLUSIONS: High intraperitoneal concentration was maintained following IP administration at 60 mg/m2. IP paclitaxel could be a promising component of radical or prophylactic treatment for the peritoneal disease when combined with concurrent or sequential systemic administration of other anticancer drugs.
METHODOLOGY: Intraperitoneal (IP) paclitaxel, a useful option for treatment of ovarian cancer, was tested in a phase I trial involving gastric carcinoma patients. The eligibility criteria included confirmed gastric carcinoma patients with uncontrollable ascites, Eastern Cooperative Oncology Group performance status < or = 2, adequate major organ functions, and clinical disease progression following prior treatment(s) with oral or intravenous anticancer drugs. The starting dose (Level 1) was 60 mg/m2 weekly for 3 weeks followed by a week of rest, and the treatment was to be continued for at least 2 cycles unless unacceptable toxicity occurred. Peritoneal and plasma samples were obtained 0 hour, 3 hours, 24 hours, and one week after the end of drug instillation for pharmacokinetic analysis
RESULTS: Of 4 patients enrolled, 3 were eligible and evaluable for toxicity. Three of the 4 patients failed to receive two cycles of treatment chiefly because of failure in the drug delivery, resulting in termination of the trial in the current form. Peak IP/plasma ratio of > 2000 was obtained at 3 hours after administration. Half-life of the drug ranged from 17.4 to 65.3 hours. Ascites diminished in 2 of 3 patients during the course of the treatment.
CONCLUSIONS: High intraperitoneal concentration was maintained following IP administration at 60 mg/m2. IP paclitaxel could be a promising component of radical or prophylactic treatment for the peritoneal disease when combined with concurrent or sequential systemic administration of other anticancer drugs.