Cancer chemotherapy and pharmacology · 2008
Biweekly docetaxel in recurrent ovarian cancer: a phase I dose finding study.
Клиническое исследование I фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Mäenpää Johanna, Leminen Arto
Аннотация
PURPOSE: To determine the maximum tolerated dose of biweekly docetaxel in patients with recurrent ovarian cancer, aiming at 70 mg/m(2).
METHODS: In this phase I trial, 8 patients were treated with biweekly docetaxel 50-65 mg/m(2). Dose-limiting toxicities were defined as any grade 3-4 non-hematological toxicity, prolonged (> or =1 week) grade 4 neutropenia or platelet count <25 x 10(9)/L, any neutropenic sepsis or febrile neutropenia, or any grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding.
RESULTS: Two groups of 3 patients each were given docetaxel 50 and 60 mg/m(2), respectively, and 2 patients received 65 mg/m(2). A total of 43 cycles were given; 26% of these were delayed, while granulocyte colony stimulating factor (G-CSF) support was used in 33%. The main toxicity was neutropenia: at dose levels of 50, 60, and 65 mg/m(2), grade 3-4 neutropenia occurred in 2/3, 3/3 and 1/2 patients, respectively. One patient experienced febrile neutropenia. A dose reduction was needed in 6 out of 13 cycles at the 65 mg/m(2) dose level. The study had to be closed prematurely due to the frequent need for G-CSF support, precluding the exploration of the 70 mg/m(2) dose. Non-hematological toxicities were mild. One patient had a partial response and six patients showed a stable disease.
CONCLUSIONS: The maximum tolerated dose of biweekly docetaxel could not be determined in this study. It seems that increasing the dose beyond 60 mg/m(2) without a routine use of G-CSF is difficult.
METHODS: In this phase I trial, 8 patients were treated with biweekly docetaxel 50-65 mg/m(2). Dose-limiting toxicities were defined as any grade 3-4 non-hematological toxicity, prolonged (> or =1 week) grade 4 neutropenia or platelet count <25 x 10(9)/L, any neutropenic sepsis or febrile neutropenia, or any grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding.
RESULTS: Two groups of 3 patients each were given docetaxel 50 and 60 mg/m(2), respectively, and 2 patients received 65 mg/m(2). A total of 43 cycles were given; 26% of these were delayed, while granulocyte colony stimulating factor (G-CSF) support was used in 33%. The main toxicity was neutropenia: at dose levels of 50, 60, and 65 mg/m(2), grade 3-4 neutropenia occurred in 2/3, 3/3 and 1/2 patients, respectively. One patient experienced febrile neutropenia. A dose reduction was needed in 6 out of 13 cycles at the 65 mg/m(2) dose level. The study had to be closed prematurely due to the frequent need for G-CSF support, precluding the exploration of the 70 mg/m(2) dose. Non-hematological toxicities were mild. One patient had a partial response and six patients showed a stable disease.
CONCLUSIONS: The maximum tolerated dose of biweekly docetaxel could not be determined in this study. It seems that increasing the dose beyond 60 mg/m(2) without a routine use of G-CSF is difficult.