Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Vermont
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Claire Verschraegen, University of Vermont
ClinicalTrials.gov Identifier:
NCT01719302
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 Intervention Phase
Operable Soft Tissue Sarcoma
Drug: Gemcitabine
Drug: Docetaxel
Drug: Pazopanib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 1 cycle (28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 4 cycles (112 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719302

Contacts
Contact: Claire Verschraegen, MD 802-656-5487 Claire.Verschraegen@vtmednet.org

Locations
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05401
Contact: Claire Verschraegen, MD    802-656-5487    Claire.Verschraegen@vtmednet.org   
Principal Investigator: Claire Verschraegen, MD         
Sponsors and Collaborators
University of Vermont
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Claire Verschraegen, Director, Hematology Oncology Unit, University of Vermont
ClinicalTrials.gov Identifier: NCT01719302     History of Changes
Other Study ID Numbers: VCC 1202
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Vermont:
Soft tissue sarcoma
gemcitabine
docetaxel
pazopanib

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

ClinicalTrials.gov processed this record on August 26, 2014