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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| weekly docetaxel and carboplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel 35mg/m2 | Drug | D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI | every 6 weeks, up to 4 year |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate | every 6 weeks, up to 4 year | |
| progression free survival | every 6 weeks, up to 4 year | |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | Seoul | 120-752 | South Korea |
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| Carboplatin AUC3 | Drug | D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks |
|
| every 6 weeks, up to 4 year |
| adverse events | every 6 weeks, up to 4 year |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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