Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma

Inclusion Criteria:

- 18 years or older

- chemotherapy naive, histologically high grade soft tissue sarcoma that is considered
to be operable

- tumor greater than 5 cm in longest dimension

- life expectancy of at least 6 months

- Zubrod performance status of 0-2

- signed informed consent

- adequate bone marrow function defined by:

1. absolute peripheral granulocyte count of >1500 cells/mm^3

2. hemoglobin >8.0 g/dl

3. platelet count >100,000/mm^3

4. absence of a regular red blood cell transfusion requirement

- adequate hepatic function defined by:

1. total bilirubin <1.5 x upper limit of normal (ULN)

2. AST, ALT and alkaline phosphatase all not more than 2.5 x ULN

- adequate renal function defined by:

1. serum creatinine <1.5 x ULN

- negative pregnancy test for women of child bearing potential

- willingness to use effective contraception while on treatment and for 3 months
thereafter

Exclusion Criteria:

- Multiple metastases (patients with 5 or fewer oligometastases that could be
resectable are eligible)

- Pregnant women or nursing mothers

- concurrent chemotherapy or radiation therapy

- severe medical problems (at the discretion of the investigator)

- history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80

- symptomatic brain metastases

- cirrhosis

- dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft
part sarcoma (ASPS)