NCT02945800

Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma

Phase II Study of Nab-Paclitaxel in Combination With Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 3 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time during and after treatment that their disease does not get worse. Researchers also want to find out if nab-paclitaxel combined with gemcitabine is safe and tolerable.

Conditions

• Osteosarcoma
• Ewing Sarcoma
• Rhabdomyosarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	nab-Paclitaxel	nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
DRUG	Gemcitabine	Gemcitabine: 1000 mg/m\^2 intravenously (IV)

Timeline

• Start date: 2016-10-25
• Primary completion: 2024-11-19
• Completion: 2025-02-17
• First posted: 2016-10-26
• Last updated: 2026-04-02
• Results posted: 2025-12-01

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study