Status:
COMPLETED
A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
Lead Sponsor:
Yonsei University
Conditions:
Sarcoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03809637
Start Date
January 10 2017
End Date
June 30 2021
Last Update
December 18 2024
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722