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Apatinib Plus IE Chemotherapy (Ifosfamide and Etoposide) for Relapsed or Refractory Osteosarcoma (AIEO)

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ClinicalTrials.gov Identifier: NCT04824352
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : July 16, 2021
Sponsor:
Collaborators:
Peking University Shougang Hospital
Jiangsu HengRui Medicine Co.
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.

Condition or disease Intervention/treatment Phase
Effect of Drug Toxicity, Drug Drug: apatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib in Combination With Ifosfamide and Etoposide (IE) for Relapsed or Refractory Osteosarcoma Progressed Upon First-line Chemotherapy (AIEO): a Prospective, Multiple-centre, Single-arm, Phase 2 Trial
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2024


Arm Intervention/treatment
Experimental: apatinib+IE
Apatinib: 500 mg QD po (BSA ≥ 1.0) or 250 mg QD po (BSA < 1.0); IE: ifosfamide 1.8 g/m2/d d1-3; etoposide 100 mg/m2/d d1-3 Q2w
Drug: apatinib
Apatinib: 500 mg QD po (BSA ≥ 1.0) or 250 mg QD po (BSA < 1.0); IE: ifosfamide 1.8 g/m2/d d1-3; etoposide 100 mg/m2/d d1-3 Q2w
Other Name: IE chemotherapy




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]
    from the start of target treatment until disease progression or death, whichever came first.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    from the date of treatment initiation to death from any cause.



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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) histologically confirmed high-grade osteosarcoma;
  • 2) initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital;
  • 3) progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy);
  • 4) measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ;
  • 5) Eastern Cooperative Oncology Group performance status ≤ 2 ;
  • 6) acceptable haematologic, hepatic, and renal function.

Exclusion Criteria:

  • those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
  • those who had severe or uncontrolled medical disorders that could jeopardize the outcomes of the study. These confounding conditions included, cardiac clinical symptoms or disease with left ventricular ejection fraction<50%, and hypertension that could not be well controlled with antihypertensive drugs.;
  • All patients were assessed by the sarcoma board including a thoracic surgeon with at least 10 years surgical experience. Patients with lung metastases only were carefully assessed for eligibility for metastasectomy, of whom those who were suitable for surgery were excluded from this study;
  • weight loss of 20% or more before illness;
  • brain or leptomeningeal metastasis;
  • surgical procedure or radiotherapy within 4 weeks of enrollment;
  • activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
  • proteinuria or hematuria, denutrition with albuminemia <25 g/L;
  • women who were pregnant or breast feeding, other malignancy;
  • positive HBV/HCV/HIV serology, and known allergy to the experimental agents.

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): NCT04824352


Contacts
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Contact: Lu Xie, M.D. +8613401044719 xie.lu@hotmail.com

Locations
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China, Beijing
Peking University Shougang Hospital Active, not recruiting
Beijing, Beijing, China, 100035
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Lu Xie, M.D.    +8613401044719    xie.lu@hotmail.com   
Sponsors and Collaborators
Peking University People's Hospital
Peking University Shougang Hospital
Jiangsu HengRui Medicine Co.
Investigators
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Principal Investigator: Wei Guo, M.D. Musculoskeletal Tumor Center of Peking University People's Hospital
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04824352    
Other Study ID Numbers: PKUPH-sarcoma 10
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
osteosarcoma
apatinib
ifosfamide
etoposide
advanced
Additional relevant MeSH terms:
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Sarcoma
Osteosarcoma
Drug-Related Side Effects and Adverse Reactions
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Chemically-Induced Disorders
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action