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

Primary Purpose

Effect of Drug, Toxicity, Drug

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

apatinib

About this trial

This is an interventional treatment trial for Effect of Drug focused on measuring osteosarcoma, apatinib, ifosfamide, etoposide, advanced

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University Shougang Hospital
Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apatinib+IE

Arm Description

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

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

NCT ID

NCT04824352

First Posted

March 27, 2021

Last Updated

July 12, 2021

Sponsor

Peking University People's Hospital

Collaborators

Peking University Shougang Hospital, Jiangsu HengRui Medicine Co.

1. Study Identification

Unique Protocol Identification Number

NCT04824352

Brief Title

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

Acronym

AIEO

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

April 1, 2023 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University People's Hospital

Collaborators

Peking University Shougang Hospital, Jiangsu HengRui Medicine Co.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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, Toxicity, Drug

Keywords

osteosarcoma, apatinib, ifosfamide, etoposide, advanced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

apatinib+IE

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

apatinib

Other Intervention Name(s)

IE chemotherapy

Intervention Description

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

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

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Xie, M.D.

Phone

+8613401044719

xie.lu@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Guo, M.D.

Organizational Affiliation

Musculoskeletal Tumor Center of Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Shougang Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100035

Country

China

Individual Site Status

Active, not recruiting

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

xie.lu@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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