The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.
Anticipated 30 subjects will be enrolled to receive Endostar, Gemcitabine and Docetaxel. Endostar at a dosage of 7.5 mg/m2 will be administered on Day 1-14 of each cycle. Gemcitabine (1000 mg/m2) will be administered on Day 1 and Day 8 of each cycle. Docetaxel (75 mg/m2) will be administered on Day 2 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is PD or until a maximum of 6 cycles. Time-to-progression (TTP) will be assessed using the Kaplan Meier method. Overall response rate (ORR) as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST (v1.1). Evaluation of 1- and 2-year overall survival will also be performed. Safety measures will be recorded using the NCI-CTCAE (v4.0).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Endostar administered at 7.5 mg/m2, intravenously (IV), on Day 1-14 every 21 days for up to 4-6 consecutive cycles
Gemcitabine administered at 1000 mg/m2, intravenously (IV), on Day 1 and Day 8, every 21 days for up to 4-6 consecutive cycles
Docetaxel administered at 75 mg/m2, intravenously (IV), on Day 2, every 21 days for up to 4-6 consecutive cycles
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGTime-to-Progression
Time to progression is defined as time from first study treatment dose to the progression disease.
Time frame: Approximately 2 years
Overall Response Rate
Time frame: Approximately 2 years
Evaluate 1-year and 2-year overall survival rates
Time frame: Approximately 2 years
Safety measures
Adverse events, Clinical and laboratory data including physical examinations, vital signs, ECG results, Use of concomitant medications
Time frame: Approximately 3 years
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