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Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE) (OAIE)

Primary Purpose

Effect of Drug, Drug, Toxicity

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib+IE
IE
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Drug focused on measuring Osteosarcoma, Apatinib, Ifosfamide, Etoposide

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. advanced recurrent and refractory osteosarcoma confirmed by histopathology;
  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 ≤ 1 ;
  6. acceptable haematologic, hepatic, and renal function.

Exclusion Criteria:

  1. those who had been previously treated with antiangiogenic TKIs and single IE chemotherapy;
  2. 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.;
  3. 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;
  4. weight loss of 20% or more before illness;
  5. brain or leptomeningeal metastasis;
  6. surgical procedure or radiotherapy within 4 weeks of enrollment;
  7. activegastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation;
  8. proteinuria or hematuria, denutrition with albuminemia <25 g/L;
  9. women who were pregnant or breast feeding, other malignancy;
  10. positive HBV/HCV/HIV serology, and known allergy to the experimental agents.

Sites / Locations

  • Peking University People's HospitalRecruiting
  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apatinib+IE group

IE group

Arm Description

IE: Ifosfamide Plus Etoposide

IE: Ifosfamide Plus Etoposide

Outcomes

Primary Outcome Measures

Progression free survival
from the start of target treatment until disease progression or death, whichever came first.

Secondary Outcome Measures

Overall survival
from the date of treatment initiation to death from any cause.

Full Information

First Posted
March 3, 2022
Last Updated
March 12, 2022
Sponsor
Peking University People's Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05277480
Brief Title
Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)
Acronym
OAIE
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, Two-arm, Phase 2 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Drug, Drug, Toxicity
Keywords
Osteosarcoma, Apatinib, Ifosfamide, Etoposide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib+IE group
Arm Type
Experimental
Arm Description
IE: Ifosfamide Plus Etoposide
Arm Title
IE group
Arm Type
Active Comparator
Arm Description
IE: Ifosfamide Plus Etoposide
Intervention Type
Drug
Intervention Name(s)
Apatinib+IE
Intervention Description
apatinib po； ifosfamide ivgtt ; etoposide ivgtt .
Intervention Type
Drug
Intervention Name(s)
IE
Intervention Description
ifosfamide ivgtt ; etoposide ivgtt .
Primary Outcome Measure Information:
Title
Progression free survival
Description
from the start of target treatment until disease progression or death, whichever came first.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
from the date of treatment initiation to death from any cause.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: advanced recurrent and refractory osteosarcoma confirmed by histopathology; initial treatment in the Orthopedic/Oncology Departments of Peking University People's Hospital or Peking University Shougang Hospital; progression less than 6 months after first-line chemotherapy with a combination of high-dose methotrexate, doxorubicin, cisplatin and ifosfamide (first-line chemotherapy); measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) ; Eastern Cooperative Oncology Group performance status ≤ 1 ; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Xie, MD
Phone
+8613401044719
Email
xie.lu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Guo, MD
Phone
+86-10-66583761
Email
bonetumor@163.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Xie, M.D.
Phone
+8613401044719
Email
xie.lu@hotmail.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo
Phone
+86-10-66583761
Email
bonetumor@163.com
First Name & Middle Initial & Last Name & Degree
Xin Sun
Phone
+86-10-66583761

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)

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