Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

University of Vermont

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stage III Adult Soft Tissue Sarcoma

Treatments: Drug: Docetaxel; Drug: Gemcitabine; Drug: Pazopanib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01719302

VCC 1202

Details and patient eligibility

About

Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.

The Phase I component of this study is designed to determine the maximum tolerated dose of pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to determine the overall response rate of the combination of docetaxel, gemcitabine and pazopanib prior to surgical resection in patients with soft tissue sarcoma.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

cohort 1

Experimental group

Treatment:

Drug: Docetaxel

Drug: Pazopanib

Drug: Gemcitabine