Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma

NCT02945800 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-04-02

Study results available
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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

DRUG

nab-Paclitaxel

nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)

DRUG

Gemcitabine

Gemcitabine: 1000 mg/m\^2 intravenously (IV)

Sponsors & Collaborators

  • National Pediatric Cancer Foundation

    collaborator OTHER
  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Javier E. Oesterheld, M.D. · Carolinas Medical Center, Levine Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-25
Primary Completion
2024-11-19
Completion
2025-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02945800 on ClinicalTrials.gov