A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: Pemetrexed, cisplatin


Participation Criteria
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Eligibility Criteria
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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 Absolute neutrophil count (ANC) ≥ 1500 /µL Platelet count ≥ 75,000/ µL Serum creatinine < 1.5 x upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN) Total bilirubin <1.5 x upper limit of normal (ULN) more than 3 months of expected survival Provision of written informed consent prior to any study procedure Exclusion Criteria: Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study' Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. Resectable lung metastases Uncontrolled or active CNS metastasis and/or carcinomatous meningitis Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ. Uncontrolled medical conditions

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pemetrexed+cisplatin<br>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. | Drug: Pemetrexed, cisplatin<br>* Pemetrexed 500mg/m2, Intravenous, Q 3weeks. Cisplatin 75mg/m2, Intravenous, Q 3weeks. Combination administration : up to 6cycles After 6 cycle, pemetrexed alone is administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event |  | every 3 weeks |