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

Primary Purpose

Sarcoma

Status
Active
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pemetrexed, cisplatin
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital, Yonsei University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pemetrexed+cisplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

progression free rate

Secondary Outcome Measures

adverse event

Full Information

First Posted
January 15, 2019
Last Updated
May 30, 2022
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03809637
Brief Title
A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
Official Title
Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pemetrexed+cisplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed, cisplatin
Intervention Description
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 Outcome Measure Information:
Title
progression free rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
adverse event
Time Frame
every 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34482181
Citation
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.
Results Reference
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A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma

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