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

NCT03809637 | Completed Phase 2

• 1 other identifier: 4-2016-0389
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• progression free rate

  12 weeks

Secondary Outcomes (1)

• adverse event

  every 3 weeks

Study Arms (1)

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.

Drug: Pemetrexed, cisplatin

Interventions

Pemetrexed, cisplatin 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.

pemetrexed+cisplatin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34482181 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: January 10, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)