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Phase II Study of nab-Paclitaxel in Combination with Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults
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.
Primary Objectives: 1. To assess the antitumor activity of nab-paclitaxel combined with gemcitabine in patients with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma using RECIST 1.1 criteria and progression-free survival. Secondary Objectives: 1. To describe the toxicities of the combination in adolescents and young adults with relapsed/refractory sarcoma. 2. To assess the immunohistochemical expression of SPARC and CAV-1 in archival tumor tissue, and compare results with treatment response. 3. To evaluate a set of radiomic biomarkers calculated from baseline and post-therapy CT scans, and compare results with treatment response.
Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); gemcitabine ()