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

NCT ID: NCT03809637

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pemetrexed, cisplatin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Hyo Song Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 34482181 (View on PubMed)

Other Identifiers

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4-2016-0389

Identifier Type: -

Identifier Source: org_study_id