A Clinicopathological Phase II Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas
Soft tissue sarcomas are a heterogeneous group of rare malignancies that account for 0.72%
of new malignancies and 0.65% of malignant deaths. Advanced sarcomas carry a poor prognosis.
Angiogenesis is a hallmark of tumour growth, and there is increasing evidence that
antiangiogenic drugs, including axitinib, can lead to tumour regression and improve patient
survival in a variety of tumours.
Patients with angiosarcoma, synovial sarcoma, leiomyosarcoma and other sarcomas will be
Patients will take axitinib 5mg tablets by mouth twice daily. This will be continued for 2
years or until disease progression, or development of limiting toxicity. In the event of
severe toxicity, axitinib will be stopped until the toxicity has improved. Treatment may be
interrupted for a maximum of 2 weeks. Following this, axitinib can be restarted at a lower
dose of 3 mg twice daily. If the toxicity has not improved sufficiently, axitinib will be
Patients will be monitored once weekly for the first month, then at 4 week intervals.
Toxicity will be closely monitored. At each clinic visit, patients will have a physical
examination and a routine blood test. A Chest x-ray, CT and/or MRI scans will be done before
study entry, then every 12 weeks and at the end of treatment. Disease evaluation will be
carried out 12 weeks after study entry, then every 12 weeks until disease progression. After
disease progression, patients will be followed up every 3 months for survival. Patients will
be followed up until death or a minimum follow up period of 1 year.
Patients will be enrolled from hospitals all over the UK.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate at 12 weeks after starting treatment, defined according to the Response Evaluation Criteria In Solid Tumours(RECIST criteria)
Disease will be assessed by CT or MRI scan 12 weeks after entry to trial and will be compared to disease measured by CT or MRI scan on entry to the trial or within 4 weeks prior to entry. Response at 12 weeks will be measured using RECIST criteria. Progression-free survival rate is measured as the number of patients who are alive and progression-free at 12 weeks divided by the total number of patients who received at least one cycle of treatment
12 weeks after trial entry, the final analysis of the primary outcome measure will take place after all patients have been followed for a minimum of 12 weeks
Penella Woll, BMedSci
Weston Park Hospital, Sheffield, UK
United Kingdom: Medicines and Healthcare Products Regulatory Agency