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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03809637
• Other study ID #: 4-2016-0389
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 10, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free rate		12 weeks
Secondary	adverse event		every 3 weeks