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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

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 21, 2019
Actual Study Start Date  ICMJE January 10, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
disease control rate [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03809637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
adverse event [ Time Frame: every 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
Official Title  ICMJE Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Pemetrexed, cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hyo Song Kim, Ph.D 82-2-2228-8124 hyosong77@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809637
Other Study ID Numbers  ICMJE 4-2016-0389
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP