Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01719302
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : June 16, 2016
Information provided by (Responsible Party):
Claire Verschraegen, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Stage III Adult Soft Tissue Sarcoma Drug: Gemcitabine Drug: Docetaxel Drug: Pazopanib Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: cohort 1 Drug: Gemcitabine
1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
Other Name: Gemzar
Drug: Docetaxel
50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
Other Name: Taxotere
Drug: Pazopanib
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 Name: Votrient

Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 1 cycle (28 days) ]

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 4 cycles (112 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719302

United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont

Responsible Party: Claire Verschraegen, Director, Hematology Oncology Unit, University of Vermont Identifier: NCT01719302     History of Changes
Other Study ID Numbers: VCC 1202
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016

Keywords provided by Claire Verschraegen, University of Vermont:
Soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators