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

NCT05277480 | Completed Phase 2 DMC

• 1 other identifier: PKUPH-sarcoma 11
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 5

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.

Conditions

Effect of Drug; Drug; Toxicity

Keywords

Osteosarcoma; Apatinib; Ifosfamide; Etoposide

Outcome Measures

Primary Outcomes (1)

• Progression free survival

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

  2 years

Secondary Outcomes (1)

• Overall survival

  3 years

Other Outcomes (7)

• Objective response rate

  2 years

• Disease control rate

  2 years

• Duration of response

  2 years

Study Arms (2)

Apatinib+IE group

EXPERIMENTAL

IE: Ifosfamide Plus Etoposide

Drug: Apatinib+IE

IE group

ACTIVE COMPARATOR

IE: Ifosfamide Plus Etoposide

Drug: IE

Interventions

Apatinib+IE DRUG

apatinib po； ifosfamide ivgtt ; etoposide ivgtt .

Apatinib+IE group

IE DRUG

ifosfamide ivgtt ; etoposide ivgtt .

IE group

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (5)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

Location

Shanghai General Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Musculoskeletal Tumor Center

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: November 26, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)