Pemetrexed and Cisplatin Chemotherapy for Advanced or Metastatic Soft Tissue Sarcoma A Phase 2 Multicenter, Open-Label Study in Four Histologic Subtypes

What this Trial Is About

Soft tissue sarcoma (STS) is a rare type of cancer arising from mesodermal tissues, representing less than 1% of all malignant tumors. This trial focuses on patients with advanced or metastatic STS who have received up to two prior lines of palliative anticancer treatments. Researchers aim to evaluate the effectiveness and safety of a combination chemotherapy regimen of pemetrexed and cisplatin, targeting different histological subtypes such as leiomyosarcoma, synovial sarcoma, and malignant peripheral nerve sheath tumor, to identify which subtypes may benefit most from this treatment. Participants will receive pemetrexed at 500 mg/m2 and cisplatin at 75 mg/m2 via intravenous infusion on Day 1 of each 21-day cycle. This combination therapy will continue through six cycles. Starting with Cycle 7, patients will receive pemetrexed alone every three weeks, also by intravenous infusion, until their disease progresses. Additionally, vitamin B12 injections and daily folic acid supplements are administered to support treatment tolerability and safety. Throughout the trial, patients will be regularly assessed for treatment response using progression-free survival rates at 12 weeks as a primary measure. Overall response rates will be evaluated every six weeks, up to one year. Safety monitoring will include evaluations of adverse events and organ function. The study will continue until disease progression, unacceptable side effects, or a decision to stop treatment by the patient or physician. The total participation time varies depending on individual disease progression and treatment tolerance.

Pemetrexed, Cisplatin With Soft Tissue Sarcoma