ARST1321, Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613)
Study ID: STU 072014-051
Researchers have found that certain types of tumors do respond to chemotherapy and some do not. Subjects will be divided into 2 treatment groups based on the type of tumor: 1) Chemotherapy Group and 2) non-Chemotherapy Group. Within each group, subjects will be randomly assigned to one of two treatment arms: standard therapy along with pazopanib or standard therapy without pazopanib. neither the doctor nor the subject will be able to choose which treatment is received. eligibility restrictions and consideration of subject/tumor characteristics will ensure that similar populations of subjects are being compared, and the number of subjects required for the study will increase the certainty that any differences in outcome or side effects are indeed due to the type of treatment they received. 1. Chemotherapy Group: These subjects have a type of tumor that is likely to respond to chemotherapy. all subjects in this group will receive standard chemotherapy (ifosfamide and doxorubicin), surgery (if possible) and radiation therapy. only some of the subjects will also receive the experimental drug pazopanib. Pazopanib will be given daily during Weeks 1-12 and 16-25 of therapy. Surgery will be planned for Week 13 and pazopanib will not be given for at least 7 days before surgery and for at least 14 days after surgery. 2. non-Standard Chemotherapy Group: These subjects either have a type of tumor that is not likely to respond to chemotherapy or have a tumor that is likely to respond but the subject is unable or unwilling to have standard chemotherapy. all subjects in this group will receive standard radiation therapy and surgery (if possible). only some of the subjects in this group will receive the experimental drug pazopanib.
* Patient must be >= 2 years of age. * Patient must have a Body Surface Area >= 0.5 m2 AND be able to swallow whole tablets. * Patient must have newly diagnosed NRSTS as defined in the protocol and which has the potential to be removed by surgery. * Sufficient tissue and blood must be available to submit for required biology research studies. * Patient must meet a minimum activity level. * Patient must have adequate bone marrow function as well as adequate kidney, liver, heart and lung function. * Patient must have a life expectancy of at least 3 months with appropriate therapy.