A study to evaluate the efficacy and safety of combination therapy with pemetrexed and cisplatin after primary treatment in metastatic / recurrent soft tissue sarcoma

Phase II study of pemetrexed plus cisplatin in patients with refractory soft tissue sarcoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003542

Enrollment

Registered

2019-02-21

Start date

2017-01-05

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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 progressio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed advanced bone and soft tissue sarcoma 2. Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide : neoadjuvnat or adjuvant chemotherapy is counted as one regimen 2. Measurable or evaluable disease (RECIST 1.1.) 3. ECOG(Eastern Cooperative Oncology Group) performance status of 0-2 4. Adequate laboratory findings 5. more than 3 months of expected survival 6. Provision of written informed consent prior to any study procedure

Exclusion criteria

Exclusion criteria: 1.Diagnosed with GIST(Gastrointestinal stromal tumor) or Kaposi sarcoma 2. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study’ 3. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. 4. Resectable lung metastases 5. Uncontrolled or active CNS(Central nervous system) metastasis and/or carcinomatous meningitis 6. 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. 7. Uncontrolled medical conditions

Design outcomes

Primary

Measure	Time frame
Rate that dose not progress from ther start of the drug to the 12th week	—

Secondary

Measure	Time frame
Adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactJeongRim Choo

Yonsei University Health System, Severance Hospital

younggaya@yuhs.ac+82-2-2228-8048

Outcome results