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CompletedNCT01719302Updated Jun 16, 2016

Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

A Phase 1/2 interventional study of Gemcitabine and Docetaxel in Stage III Adult Soft Tissue Sarcoma, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-16.

Sponsored by University of Vermont · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Stage III Adult Soft Tissue Sarcoma

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Keywords

  • Soft tissue sarcoma
  • gemcitabine
  • docetaxel
  • pazopanib
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    cohort 1

    Drug: Gemcitabine · Drug: Docetaxel · Drug: Pazopanib

Interventions

  • DrugGemcitabine

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

    Also known as: Gemzar

  • DrugDocetaxel

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

    Also known as: Taxotere

  • DrugPazopanib

    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.

    Also known as: Votrient

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What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: 1 cycle (28 days)

Secondary outcomes

  1. Overall response rate

    Time frame: 4 cycles (112 days)

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Study locations

1 site
  • Fletcher Allen Health Care
    Burlington, Vermont 05401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01719302
Lead sponsor
University of Vermont
Collaborators
Novartis
Responsible party
Claire Verschraegen (Director, Hematology Oncology Unit, University of Vermont) — Principal investigator
First posted
Nov 1, 2012
Start date
Oct 2012
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Jun 16, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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