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The yearly incidence of soft-tissue sarcomas(STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. After the standard 1st line chemotherapy with doxorubicin, the only a few treatment option is available. Recently, pemetrexed, a novel multitargeted antifolate, has shown modest activity as a single agent lung cancer and mesothelioma. In patients with refractory STS, pemetrexed is well tolerated and moderately effective. Based on the background, investigators planned to conduct the phase II trial of pemetrexed in combination with cisplatin for metastatic/recurred soft-tissue sarcomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pemetrexed+cisplatin | Experimental | Patients with metastatic sarcoma who underwent one chemotherapy regimens are treated with the combination of pemetrexed and cisplatin, and the treatment is repeated until the disease progression. pemetrexed 500 mg / m2 (day 1) and cisplatin 75 mg / m2 (day 1) are intravenously injected. 21 days is one cycle, and it is carried out by co-administration up to 6 cycles. After 7 cycles, intravenous injection of pemetrexed alone at intervals of 3 weeks until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed, cisplatin | Drug | Pemetrexed 500mg/m2, Intravenous, Q 3weeks. Cisplatin 75mg/m2, Intravenous, Q 3weeks. Combination administration : up to 6cycles After 6 cycle, pemetrexed alone is administered. |
| Measure | Description | Time Frame |
|---|---|---|
| progression free rate | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | every 3 weeks |
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Inclusion Criteria:
Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide
Measurable or evaluable disease (RECIST 1.1.)
Age ≥19 years
ECOG performance status of 0-2
Adequate laboratory findings
more than 3 months of expected survival
Provision of written informed consent prior to any study procedure
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34482181 | Derived | Kim JH, Kim SH, Jeon MK, Kim JE, Kim KH, Yun KH, Jeung HC, Rha SY, Ahn JH, Kim HS. Pemetrexed plus cisplatin in patients with previously treated advanced sarcoma: a multicenter, single-arm, phase II trial. ESMO Open. 2021 Oct;6(5):100249. doi: 10.1016/j.esmoop.2021.100249. Epub 2021 Sep 2. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |