A Single-Arm, Multicenter, Open-Label, Phase 2 study of Pemetrexed/Cisplatin Chemotherapy for Patients With Metastatic/Recurrent Soft Tissue Sarcoma in 4- independent histologic subtypes

Yonsei University Health System, Severance Hospital0 个研究点目标入组 164 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

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•? 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

•? 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

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