This is a single arm phase II clinical study to evaluate the efficacy and safety of metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced sarcomas.
Eligible patients will receive continuous metronomic oral cyclophosphamide at a dose of 50mg daily. Tumor assessments will be performed at baseline and every 6 weeks thereafter to assess response and disease progression. Toxicity will be monitored throughout treatment. The study's primary end point is defined as clinical benefit rate (CBR) at 12 weeks as a measure of disease control. The study is designed to distinguish a favorable true PFR of 40% from a null rate of 20% \[Van Glabbeke et al. EJC 2002\]. With a CBR of 40%, metronomic oral cyclophosphamide at this dose and schedule in this patient population will be considered worthy of further evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
50mg daily
National Cancer Centre Singapore
Singapore, Singapore, Singapore
Clinical benefit as defined by the composite of complete response (CR), partial response (PR) and stable disease (SD) lasting > 12 weeks per RECIST 1.1 as a measure of disease control
Time frame: 24 months
Assessment of objective response rate (ORR)
Time frame: 24 months
Assessment of progression free survival
Time frame: 24 months
Assessment on duration of response to oral metronomic cyclophosphamide in patients who exhibit objective responses
Time frame: 24 months
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