Spots Global Cancer Trial Database for Clinical Study of Metronomic Oral Cyclophosphamide in Patients With Advanced Sarcomas

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Trial Identification

Brief Title: Clinical Study of Metronomic Oral Cyclophosphamide in Patients With Advanced Sarcomas

Official Title: Phase II Clinical Study of Metronomic Oral Cyclophosphamide in Elderly and/or Pre-treated Patients With Advanced Sarcomas

Study ID: NCT01716689

Conditions

Sarcoma

Interventions

oral cyclophosphamide

Study Description

Brief Summary: 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.

Detailed Description: 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.