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

Phase II 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcoma
• Intervention / Treatment: Drug: Pemetrexed, cisplatin

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide
2. Measurable or evaluable disease (RECIST 1.1.)
3. Age ≥19 years
4. ECOG performance status of 0-2

5. 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)
6. more than 3 months of expected survival
7. Provision of written informed consent prior to any study procedure

Exclusion Criteria:

1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study'
2. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
3. Resectable lung metastases
4. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
5. 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.
6. Uncontrolled medical conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: pemetrexed+cisplatin; Patients with metastatic sarcoma who underwent one chemotherapy regimens are treated with the combination of pemetrexed and cisplatin, and the treatment is repeated until the disease progression. pemetrexed 500 mg / m2 (day 1) and cisplatin 75 mg / m2 (day 1) are intravenously injected. 21 days is one cycle, and it is carried out by co-administration up to 6 cycles. After 7 cycles, intravenous injection of pemetrexed alone at intervals of 3 weeks until disease progression.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression free rate	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse event	every 3 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Kim JH, Kim SH, Jeon MK, Kim JE, Kim KH, Yun KH, Jeung HC, Rha SY, Ahn JH, Kim HS. Pemetrexed plus cisplatin in patients with previously treated advanced sarcoma: a multicenter, single-arm, phase II trial. ESMO Open. 2021 Oct;6(5):100249. doi: 10.1016/j.esmoop.2021.100249. Epub 2021 Sep 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2017
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (ACTUAL): January 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Cisplatin; Pemetrexed
• Other Study ID Numbers: 4-2016-0389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No