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

Who is this study for? Patients with Sarcoma
What treatments are being studied? Pemetrexed+Cisplatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Soft tissue sarcoma (STS) is rare malignancy of mesodermal origin, representing less than 1% of all malignant neoplasms. They are a group of diseases encompassing diverse histological subtypes with very different biomorphologies, prognoses, and responses to treatments. At advanced stages of STS, anticancer treatments are less effective and the prognosis is poor with a median survival of 8 to 18 months. Doxorubicin and ifosfamide given each alone or in their combination have represented the mainstream of anticancer treatments in metastatic STS. However, salvage treatments for patients with progression after doxorubicin/ifosfamide-based treatment are limited and anticancer agents such as gemcitabine/docetaxel, pazopanib, eribulin and trabectedin are currently used as a standard of care (SOC). For metastatic sarcoma, a study of pemetrexed alone in patients with refractory STS who have progressed after doxorubicin and/or ifosfamide-based anticancer treatment was conducted. In this study including 48 patients, most of whom had relatively poor course of disease with disease progression after the 2nd- and/or 3rd-line treatment, pemetrexed was well tolerated and associated with 5% of response rate and 33% of 3-month progression-free rates suggesting potential antitumor efficacy with good tolerability profile with refractory STS. However, as conventional agents have showed different efficacy depending on various subtypes of STS, a confirmatory study to see clinical utilities of a given regimen by subtype is required also for pemetrexed/cisplatin. Therefore, the investigators intend to proceed this phase 2 clinical trial to evaluate the efficacy and safety of pemetrexed/cisplatin combination therapy in patients with advanced/metastatic STS who received up to two-lines of prior palliative anticancer treatments with histological subtype-specific cohorts (leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor, and others) in order to provide a basis for a subsequent phase 3 study by selecting histological subtype(s) in which the efficacy of study regimen is to be proven.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Hyo Song Kim, MD, Ph.D
hyosong77@yuhs.ac
82-2-2228-8124
Time Frame
Start Date: 2020-12-22
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 164
Treatments
Experimental: pemetrexed+cisplatin
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 Cycle 6. Starting from Cycle 7, pemetrexed alone will be administered every 3 weeks (Q3W) as IV infusion until disease progression.
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov

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