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NCT Number: NCT03809637

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

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide
  • Measurable or evaluable disease (RECIST 1.1.)
  • Age ≥19 years
  • ECOG performance status of 0-2
  • Adequate laboratory findings
  • Absolute neutrophil count (ANC) ≥ 1500 /µL
  • Platelet count ≥ 75,000/ µL
  • Serum creatinine < 1.5 x upper limit of normal (ULN)
  • AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN)
  • Total bilirubin <1.5 x upper limit of normal (ULN)
  • more than 3 months of expected survival
  • Provision of written informed consent prior to any study procedure

Exclusion criteria

  • Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study'
  • Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
  • Resectable lung metastases
  • Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
  • Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
  • Uncontrolled medical conditions

Treatment and study plan

Pemetrexed, cisplatin

Drug

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

Primary outcomes

  1. progression free rate

    Time frame: 12 weeks

Secondary outcomes

  1. adverse event

    Time frame: every 3 weeks

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2019
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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