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OpenTrials
Completed

NCT Number: NCT01719302

Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

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.

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Key information

Conditions

Stage III Adult Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • absolute peripheral granulocyte count of >1500 cells/mm^3
  • hemoglobin >8.0 g/dl
  • platelet count >100,000/mm^3
  • absence of a regular red blood cell transfusion requirement
  • adequate hepatic function defined by:
  • total bilirubin <1.5 x upper limit of normal (ULN)
  • AST, ALT and alkaline phosphatase all not more than 2.5 x ULN
  • adequate renal function defined by:
  • 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)

Treatment and study plan

Gemcitabine

Drug

1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles

Other names: Gemzar

docetaxel

Drug

50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles

Other names: Taxotere

Pazopanib

Drug

Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.

Other names: Votrient

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: 1 cycle (28 days)

Secondary outcomes

  1. Overall response rate

    Time frame: 4 cycles (112 days)

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2012
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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