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

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ClinicalTrials.gov Identifier: NCT03809637
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
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 : January 10, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020


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.




Primary Outcome Measures :
  1. disease control rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. adverse event [ Time Frame: every 3 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 100,000/ 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809637


Contacts
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Contact: Hyo Song Kim, Ph.D 82-2-2228-8124 hyosong77@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: Hyo Song Kim    82-2-2228-8124    hyosong77@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03809637     History of Changes
Other Study ID Numbers: 4-2016-0389
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors