NCT03742193

Pulmonary Resectable Metastases of Osteosarcoma With Anti-angiogenics and CHemotherapy

A Phase II Study of Gemcitabine-docetaxel Chemotherapy With Anti-angiogenic Therapy for Pulmonary Resectable Metastases of Osteosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of Second-line chemotherapy combined with Apatinib for the patients with resectable pulmonary metastasis of osteosarcoma.

Detailed description

After standard chemotherapy and surgery for the localized disease, pulmonary metastases of osteosarcoma occurs in up to 40% of cases and still remain challenging without satisfactory regimen. Apatinib is a oral kinase inhibitor of receptor tyrosine targeting VEGFR2. A pilot study indicated that Apatinib improved the PFS after multi-line chemotherapy failure, and might partly reversed chemo-refractory status for advanced osteosarcoma. Thus, the investigators explored the efficacy of combining Apatinib with current available second-line chemotherapy compared to chemotherapy alone for treating first resectable pulmonary metastases of osteosarcoma following the failure of first-line chemotherapy and wide/radical-margin surgery. Participants will receive 250 mg of apatinib twice daily combined with gemcitabine-docetaxel (GD) regimen before and after the surgical resection of the pulmonary metastases. Osteosarcoma patients with pulmonary recurrence only at baseline will be recruited in the study. The primary end point is progression-free survival rate (PFR) compared with historical control. A12 month PFR of 30% or less is considered inactive, while a 12 month PFR of 50% or greater is regarded as of interest for additional development. With a type I error rate of 5% and a power of 83%, the number of patients needed for this design is 43.

Conditions

• Osteosarcoma
• Pulmonary Metastases
• Apatinib

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib 250mg tablet by mouth, bid. 48 hrs break before and 96 hrs after the surgical resection of the pulmonary metastases.
DRUG	GD regimen	One cycle: gemcitabine 900 mg/m\^2 over 90 min on Day 1, and gemcitabine 900 mg/m\^2 and docetaxel 75 mg/m\^2 on Day 8. Every 21 days were eligible. 1\~2 -week break before and 2-week break after the surgical resection of the pulmonary metastases is taken.

Timeline

• Start date: 2019-08-11
• Primary completion: 2023-11-15
• Completion: 2023-12-30
• First posted: 2018-11-15
• Last updated: 2023-11-01

Locations

1 site across 1 country: China