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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

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Ewing Sarcoma
Trial Phase
Phase II
Eligibility
12 - 30 Years, Male and Female
Study Type
Treatment
NCD ID
NCT02945800
Protocol IDs
MCC-18613 (primary)
NCI-2016-01837
Study Sponsor
Moffitt Cancer Center

Summary

This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride work in treating teenagers or young adults with osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or soft tissue sarcoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Objectives

PRIMARY OBJECTIVES:
I. To assess the antitumor activity of nab-paclitaxel combined with gemcitabine hydrochloride (gemcitabine) in patients with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and progression-free survival.

SECONDARY OBJECTIVES:
I. To describe the toxicities of the combination in adolescents and young adults with relapsed/refractory sarcoma.
II. To assess the immunohistochemical expression of SPARC and CAV-1 in archival tumor tissue, and compare results with treatment response.
III. To evaluate a set of radiomic biomarkers calculated from baseline and post-therapy computed tomography (CT) scans, and compare results with treatment response.
IV. To quantify circulating tumor cells (CTC) in patients with recurrent or refractory sarcomas, and determine if CTC changes reflect response to therapy or predict risk of progression.

OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 90 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 3 months.
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