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

Sponsor

Yonsei University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03809637

Collaborator

(none)

Enrollment

Location

Arm

71.7

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: Pemetrexed, cisplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2017

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

progression free rate [12 weeks]

Secondary Outcome Measures

adverse event [every 3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyo Song Kim, professor, Yonsei University

ClinicalTrials.gov Identifier:

NCT03809637

Other Study ID Numbers:

4-2016-0389

First Posted:

Jan 18, 2019

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sarcoma

Pemetrexed

Study Results

No Results Posted as of Jun 1, 2022