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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Operable Soft Tissue Sarcoma

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Trial Information

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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

1 cycle (28 days)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

VCC 1202

NCT ID:

NCT01719302

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Operable Soft Tissue Sarcoma
  • Soft tissue sarcoma
  • gemcitabine
  • docetaxel
  • pazopanib
  • Sarcoma

Name

Location

Fletcher Allen Health CareBurlington, Vermont  05401