Clinical Trial: Cancer

ARST1321 Non-Rhabdomyosarcoma Soft Tissue Sarcoma Study (PRO00002426)

Full Name

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)

Description

If you choose to participate, you will be randomly assigned to one of 4 regimens.  If you are assigned to Regimen A (the experimental regimen), you will take pazopanib hydrochloride once a day (QD) by mouth (PO) on weeks 1-12, ifosfamide IV over 204 hours on days 1-3 on weeks 1, 4, 7, 10, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4.  You will undergo radiation therapy on y weeks 4-10.  On week 13, you will undergo surgery.  You will then take pazopanib hydrochloride once a day by mouth on weeks 16-25, ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22.  You will then undergo radiation therapy on weeks 16-25. 

If you are assigned to Regimen B, you will receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4.  You will then undergo radiation therapy on weeks 4-10.  You will then undergo surgery on week 13.  You will then receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22.  Patients undergo radiation therapy on weeks 16-25. 

If you are assigned to Regimen C (also an experimental arm), you will take pazopanib hydrochloride once a day by mouth on weeks 1-9.  You with then undergo radiation therapy on weeks 1-7.  On week 10, you will undergo surgery.  You will then take pazopanib hydrochloride once a day by mouth on weeks 13-25.  You will then undergo radiation therapy on weeks 13-16. 

If you are assigned to Regimen D, you will undergo radiation therapy on weeks 1-7.  You will then undergo surgery on week 10.  You will then undergo radiation therapy on weeks 13-16. 

Eligibility

Inclusion Criteria

Must be 2 years and older

Must have newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk

Must not have known central nervous system (CNS) metastases

Must not have evidence of active bleeding or bleeding diathesis

Must be able to swallow whole tablets