None listed
Conditions
Interventions
Drug : Pemetrexed 500 mg/m2 (Day 1) and cisplatin 75 mg/m2 (Day 1) will be given via intravenous (IV) infusion. Each cycle consists of 21 days, and this combination therapy will be continued until Cyc
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Has histologically confirmed, advanced/metastatic STS which has progressed after prior anticancer treatment(s) (= 2 regimens) ? Is = 19 years of age at the time of study entry ? Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ? Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ? Has laboratory values indicating adequate organ function as follows: ? Is a documented postmenopausal woman, or is a premenopausal woman with negative urine or serum pregnancy test ? Is willing to comply with the protocol throughout the study ? Has a life expectancy = 12 weeks
Exclusion criteria
Exclusion criteria: ? Has previously received more than 2 regimens of cytotoxic chemotherapy ? Has received chemotherapy, surgery to major organ, or radiotherapy within the last 2 weeks; except for palliative radiation therapy for symptom relief, which is permitted. ? Has ongoing toxicity (= CTCAE grade 2) from previous anticancer therapy (except for alopecia, vitiligo, and laboratory values described in the inclusion criteria) ? Has central nervous system (CNS) metastases requiring active treatment ? Has a diagnosis of second malignancy or has a history of active malignancy within the past 3 years (except for cured basal cell cancer of the skin, cervical cancer in situ, and thyroid cancer) ? Has other medical conditions where the study treatment is intolerable ? Has a history of active infection ? Has hypersensitivity to pemetrexed or any of its excipients ? Co-administration with yellow fever vaccine ? Is a female who is pregnant, potentially pregnant, or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) rate at Week 12 (PFR 12) based on RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Countries
Korea, Republic of
Contacts
Public ContactHyoSong Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed