Combination treatment of pemetrexed and cisplatin for advanced soft tissue sarcoma
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
This study is testing if a combination of two cancer drugs, pemetrexed and cisplatin, can help people with advanced soft tissue sarcoma who haven't responded to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy, Doxorubicin |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04605770 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of a combination treatment using pemetrexed and cisplatin in patients with advanced or metastatic soft tissue sarcoma (STS) who have previously progressed after standard chemotherapy. The study aims to assess the response of these patients to the new treatment regimen, which may offer an alternative for those with limited options. Eligible participants must have measurable disease and adequate organ function, and they will be monitored for treatment outcomes and side effects throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with histologically confirmed advanced or metastatic soft tissue sarcoma and a performance status of 0 or 1.
Not a fit: Patients who have received more than two regimens of cytotoxic chemotherapy or have ongoing toxicity from previous treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced soft tissue sarcoma who have exhausted standard treatment options.
How similar studies have performed: While there have been studies on pemetrexed alone for refractory STS, the combination with cisplatin is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed, advanced/metastatic STS * Is ≥ 19 years of age * Eastern Cooperative Oncology Group performance status of 0 or 1 * measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 * laboratory values indicating adequate organ function * a documented postmenopausal woman, or is a premenopausal woman with negative urine or serum pregnancy test * life expectancy ≥ 12 weeks Exclusion Criteria: * previously received more than 2 regimens of cytotoxic chemotherapy * received chemotherapy, surgery to major organ, or radiotherapy within the last 2 weeks * ongoing toxicity (≥ CTCAE grade 2) from previous anticancer therapy * central nervous system (CNS) metastases requiring active treatment * diagnosis of second malignancy or has a history of active malignancy within the past 3 years * other medical conditions where the study treatment is intolerable * history of active infection * hypersensitivity to pemetrexed or any of its excipients * Co-administration with yellow fever vaccine * pregnancy
Where this trial is running
Seoul
- Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hyo Song Kim, MD, Ph.D
- Email: hyosong77@yuhs.ac
- Phone: 82-2-2228-8124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.