A Trial Comparing Two Medications as First Treatment in Elderly Patients With Metastatic or Advanced Soft Tissue Sarcoma
Status:
Completed
Trial end date:
2017-07-11
Target enrollment:
Participant gender:
Summary
Patients with a locally advanced or metastatic (i.e., there are already metastases of the
diagnosed tumor in the body outside the primary lesion) soft tissue sarcoma will be recruited
for this study. The minimum age to enter the study is 60 years.
Therapy with doxorubicin is the mainstay of palliative chemotherapy for these patients, which
is associated with hematological toxicity and an increase of the infection rate. Pazopanib is
known to rarely induce hematological toxicity or to trigger infection. We therefore assume
that pazopanib exerts similar activity while decreasing neutropenia and neutropenic fever.
Pazopanib is already approved in the U.S. and Europe for the treatment of advanced soft
tissue sarcoma.
Doxorubicin and pazopanib will be randomly allocated to either receive doxorubicin or
pazopanib in a phase II clinical trial. The aim of this study is to measure the treatment
effect (reduction in tumor size or tumor stabilization) for both drugs, as well as the
survival rate, and the duration of tumor control by the different therapies. A further
objective is to measure the quality of life by standardized questionnaires throughout the
course of treatment.