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)