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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
University Hospitals Leuven, Leuven Cancer Institute, Dept. of General Medical Oncology
Leuven, Flemish Brabant, Belgium
Heidelberg University Hospital, Department of Internal Medicine, Hematology, Oncology and Rheumatology
Heidelberg, Baden-Wurttemberg, Germany
University Medical Centre Mannheim, Surgical oncology
Mannheim, Baden-Wurttemberg, Germany
Medical University Tuebingen, Center for Soft Tissue Sarcoma, GIST and Bone Tumors
Tübingen, Baden-Wurttemberg, Germany
LMU University hospital Munich Grosshadern, Medical Dept. III
Munich, Bavaria, Germany
Hannover Medical School, Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation
Hanover, Lower Saxony, Germany
University Hospital RWTH Aachen, Medical Dept. IV
Aachen, North Rhine-Westphalia, Germany
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
University Hospital Essen, West-German Tumor Center
Essen, North Rhine-Westphalia, Germany
University Hospital Carl Gustav Carus, Internal Medicine Dept. I
Dresden, Saxony, Germany
...and 1 more locations
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40 months
Time frame: 10 to 40 months
Change of rates of neutrophil granulocytopenia grade 4 (Day 1 - End of Trial (4 weeks after last IMP dose)), Change in rates of febrile neutropenia (Day 1 - End of Trial (4 weeks after last IMP dose))
Time frame: 10 months up to 40 months
Change from date randomization in progression-free rate at 12 weeks. Change from date randomization in progression-free rate at 26 weeks.
Time frame: 10 months up to 40 months
Change from date of randomization in overall survival to date of death (from any cause)
Time frame: 10 months up to 40 months
Change from date of randomization in objective response rate at 12 weeks. Change from date of randomization in objective response rate at 26 weeks.
Time frame: 10 months up to 40 months
Collection of life quality questionnaires (QLQ-C30) at baseline, after 3, 6, 9, 12, 15, 19, and 26 weeks from date of randomization and end of therapy (EOT). Thereafter, assessment will be performed every 12 weeks until progression.
Time frame: 10 months up to 40 months
Geriatric assessments from the date of baseline, after 12 and 26 weeks, and then every 12 weeks until progression
Time frame: 10 months up to 40 months
Change in expression of certain biomarkers in blood to predict either response or resistance to pazopanib from baseline, week 2, day 1 of every cycle, week 19 and 26, end of therapy, and as part of the extension study every 6 weeks.
Time frame: 10 months up to 40 months
Time from date of randomization until the date of first objective documentation of disease progression, treatment failure, or death due to any cause, whichever occurs first.
Time frame: 10 months up to 40 months
Time to onset of response after 6, 12, 19 and 26 weeks from date of randomization
Time frame: 10 months up to 40 months
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