This is the phase II, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and secondary end point includes disease control rate, progression free survival, overall survival and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
Severance Hospital
Seoul, Seoul, South Korea
Response Rate
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
Time frame: every 6 weeks, up to 4 year
disease control rate
Time frame: every 6 weeks, up to 4 year
progression free survival
Time frame: every 6 weeks, up to 4 year
overall survival
Time frame: every 6 weeks, up to 4 year
adverse events
Time frame: every 6 weeks, up to 4 year
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