Apatinib + Ifosfamide and Etoposide for Relapsed or Refractory Osteosarcoma

Effect of Drug Clinical Trial

Official title:

Apatinib+Ifosfamide and Etoposide (IE) Versus IE Alone for Relapsed or Refractory Osteosarcoma: a Real-world Study in Two Centers in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690231
• Other study ID #: PKUPH-sarcoma 14
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Today, using a multi-modal approach consisting of preoperative (neoadjuvant) systemic polychemotherapy followed by local surgical therapy and then postoperative (adjuvant) chemotherapy, long-term, disease-free survival can be achieved in 60- 70% of osteosarcoma patients. However treatment options for osteosarcomas, especially in the setting of metastatic or unresectable disease, are very scarce. Apatinib has been proved to be an effective agent to prolong progression-free survival in advanced osteosarcoma. But after 4-6 months' treatment, secondary resistance always occurred with musculoskeletal lesions' progression or new metastasis. Nowadays giving therapeutic doses of IE concurrently with anti-angiogenesis tyrosine kinase inhibitors is a conceptually attractive strategy for treating patients with refractory osteosarcoma according to prospective trial of lenvatinib +IE reported by Gaspar et al at 2019 ESMO and 2020 ESMO. Thus This study was designed to review our experience in real world for off-label use and characterize the toxicity profile of concurrent apatinib+IE and IE alone in patients with relapsed or refractory osteosarcoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• histological diagnosis of osteosarcoma (confirmed by central pathological review by an expert pathologist from the Peking University People's Hospital)
• objective disease progression within 3 months prior to treatment according to RECIST 1.1
• previously treated with one to two lines of chemotherapy for metastatic disease
• have an adequate performance status (adults:Eastern Cooperative Oncology Group [ECOG] performance status of 0-1;children aged >12 years: a score of =60% on the Karnofsky performance scale; children aged =12 years a score of =60% on the Lansky scale)

Exclusion Criteria:

• a life expectancy of less than 3 months
• patients had to have adequate bone marrow function, normal renal function, normal liver function, and normal pancreatic function
• no other malignant tumors
• no malignant pleural and peritoneal effusion

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Effect of Drug
• Osteosarcoma
• Secondary Resistance
• Toxicity, Drug

Intervention

Drug:
• Apatinib Mesylate
apatinib orally daily and ifosfamide 1.8mg/m2/d d1-3, etoposide 100mg/m2/d d1-3
• ifosfamide and etoposide
ifosfamide and etoposide

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Peking University Shougang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Xie L, Xu J, Sun X, Tang X, Yan T, Yang R, Guo W. Apatinib for Advanced Osteosarcoma after Failure of Standard Multimodal Therapy: An Open Label Phase II Clinical Trial. Oncologist. 2019 Jul;24(7):e542-e550. doi: 10.1634/theoncologist.2018-0542. Epub 2018 Dec 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event-free survival	from start treatment to any events/death	24 months
Secondary	progression-free survival	from start treatment to progression/death	24 months
Secondary	overall survival	from start treatment to death	24 months