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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
nab-Paclitaxel: 125 mg/m\^2 intravenously (IV)
Gemcitabine: 1000 mg/m\^2 intravenously (IV)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
A.I. duPont Hospital for Children, Delaware - Nemours
Wilmington, Delaware, United States
Shand's Hospital for Children at the University of Florida
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Holtz Children's Hospital at the University of Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center
Tampa, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
...and 4 more locations
Response Rate
Treatment response will be assessed with the most relevant imaging studies (e.g., CT or MRI) after every two cycles. Standard Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used to assess responses. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: 13 months
Progression Free Survival (PFS)
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm).
Time frame: 13 months
Occurrence of Study Treatment Related Adverse Events
Adverse Events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0, deemed to be caused by study treatment.
Time frame: 13 months
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