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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: Pemetrexed, cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03809637

4-2016-0389

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

pemetrexed+cisplatin

Experimental group

Description:

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.

Treatment:

Drug: Pemetrexed, cisplatin