Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Cremophor EL-free polymeric micelle of paclitaxel
Samyang Biopharmaceuticals
Seoul, South Korea
RECRUITINGThe maximum tolerated dose (MTD)
MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT
Time frame: 2 years
The recommended dose for the phase II study
Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups
Time frame: 2 years
The dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) was defined as one of the following cases. NCI CTCAE V3.0 Grade 3 or more hypersensitivity despite premedication, Non-Hematological Toxicity other than nausea and vomiting, Hematological toxicity.
Time frame: 2 years
Toxicities
Clinical/laboratory toxicities were monitored after the treatment, in order to evaluate safety and tolerance of the test drugs, and adverse events, which were maintained until visit on discontinuation date, were followed until recovered or stabilized
Time frame: 2 years
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