CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Pemetrexed, cisplatindrug
Likely dose
Pemetrexed, cisplatin 500mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03809637
NCT03809637Phase 2Completed
CompareCT.gov

Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma

Yonsei University·interventional·Posted Jan 18, 2019·Updated Dec 18, 2024

In Brief

A Phase 2 clinical trial evaluating Pemetrexed, cisplatin for Sarcoma. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The yearly incidence of soft-tissue sarcomas(STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. After the standard 1st line chemotherapy with doxorubicin, the only a few treatment option is available. Recently, pemetrexed, a novel multitargeted antifolate, has shown modest activity as a single agent lung cancer and mesothelioma. In patients with refractory STS, pemetrexed is well tolerated and moderately effective. Based on the background, investigators planned to conduct the phase II trial of pemetrexed in combination with cisplatin for metastatic/recurred soft-tissue sarcomas.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 18, 2019
Enrollment StartJan 10, 2017
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.5 years ago

Interventions

Pemetrexed, cisplatindrug

Pemetrexed 500mg/m2, Intravenous, Q 3weeks. Cisplatin 75mg/m2, Intravenous, Q 3weeks. Combination administration : up to 6cycles After 6 cycle, pemetrexed alone is administered.