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Brief Title: A Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas
Official Title: A Clinicopathological Phase II Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas
Study ID: NCT01140737
Brief Summary: The study objective is to evaluate the therapeutic activity, safety and tolerability of axitinib in patients with advanced/metastatic soft tissue sarcoma who are unsuitable for or have relapsed after standard chemotherapy. The therapeutic activity will be separately assessed in angiosarcoma, synovial sarcoma, leiomyosarcomas and other sarcomas.
Detailed Description: 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 separately evaluated. 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 permanently stopped. 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.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Bristol Haematology & Oncology Centre, Bristol, , United Kingdom
St. James's Hospital, Leeds, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Royal Marsden, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
Christies, Manchester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Penella Woll, Sheffield, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Clatterbridge Centre for Oncology, Wirral, , United Kingdom
Name: Penella Woll, BMedSci
Affiliation: Weston Park Hospital, Sheffield, UK
Role: PRINCIPAL_INVESTIGATOR