Apatinib + Ifosfamide and Etoposide for Relapsed or Refractory Osteosarcoma

NCT04690231 | Completed

• 1 other identifier: PKUPH-sarcoma 14
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effect of Drug; Toxicity, Drug; Secondary Resistance

Keywords

osteosarcoma; apatinib; ifosfamide and etoposide; prognosis; toxicity

Outcome Measures

Primary Outcomes (1)

• event-free survival

  from start treatment to any events/death

  24 months

Secondary Outcomes (2)

• progression-free survival

  24 months

• overall survival

  24 months

Study Arms (2)

Apatinib+IE

EXPERIMENTAL

Drug: Apatinib Mesylate; Drug: ifosfamide and etoposide

IE

ACTIVE COMPARATOR

Drug: ifosfamide and etoposide

Interventions

Apatinib Mesylate DRUG

apatinib orally daily and ifosfamide 1.8mg/m2/d d1-3, etoposide 100mg/m2/d d1-3

Also known as: ifosfamide and etoposide

Apatinib+IE

ifosfamide and etoposide DRUG

ifosfamide and etoposide

Apatinib+IE; IE

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University Shougang Hospital: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related 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.

  PMID: 30559126 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Osteosarcoma

Interventions

apatinib; Ifosfamide; Etoposide

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: December 30, 2020
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)