A Phase 2 study of Pemetrexed/Cisplatin Chemotherapy for Patients With Metastatic/Recurrent Soft Tissue Sarcoma
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 164
? 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) rate at Week 12 (PFR 12) based on RECIST 1.1
- Secondary Outcome Measures
Name Time Method overall response rate