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Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

Primary Purpose

Stage III Adult Soft Tissue Sarcoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Docetaxel
Pazopanib
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Adult Soft Tissue Sarcoma focused on measuring Soft tissue sarcoma, gemcitabine, docetaxel, pazopanib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Fletcher Allen Health Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cohort 1

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose

Secondary Outcome Measures

Overall response rate

Full Information

First Posted
October 29, 2012
Last Updated
June 14, 2016
Sponsor
University of Vermont
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01719302
Brief Title
Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma
Official Title
Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Adult Soft Tissue Sarcoma
Keywords
Soft tissue sarcoma, gemcitabine, docetaxel, pazopanib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cohort 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
Votrient
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Time Frame
1 cycle (28 days)
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
4 cycles (112 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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)
Facility Information:
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

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Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

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