Nab-Paclitaxel and Gemcitabine Hydrochloride in Treating Teenagers or Young Adults with Recurrent or Refractory Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, or Soft Tissue Sarcoma

Active:	Yes
Cancer Type:	Sarcoma	NCT ID:	NCT02945800
Trial Phases:	Phase II	Protocol IDs:	MCC-18613 (primary) NCI-2016-01837
Eligibility:	3 - 30 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Moffitt Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT02945800

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 (recurrent) or does not respond to treatment (refractory). Chemotherapy drugs, 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 OBJECTIVE:
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 cycles 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.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.