SarcomaPhase 2NCT03809637
A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
A Phase 2 study testing Pemetrexed, cisplatin in people with Sarcoma, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Pemetrexed, cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2017to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul, 03722
About this study
Official title: 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.
- Conditions
- Sarcoma
- Being tested
- Pemetrexed, cisplatin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed+cisplatin | Experimental | 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. Receives: Drug: Pemetrexed, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free rate
Measured: 12 weeks
Secondary outcomes (1)
adverse event
Measured: every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start10 Jan 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo Song Kim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809637
- Sponsor's protocol ID
- 4-2016-0389
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2019
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34482181
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03809637
- Acronym / sponsor ID
- 4-2016-0389
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pemetrexed+cisplatin | Experimental | Drug: Pemetrexed, cisplatinPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemetrexed, cisplatinPemetrexed 500mg/m2, Intravenous, Q 3weeks. Cisplatin 75mg/m2, Intravenous, Q 3weeks. Combination administration : up to 6cycles After 6 cycle, pemetrexed alone is administered. | Drug | pemetrexed+cisplatin |
Primary outcome
progression free rate
Time frame: 12 weeks
1 secondary outcome
adverse event
Time frame: every 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 34482181Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed, cisplatin in people with Sarcoma, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03809637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.