Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma
NCT ID: NCT01719302
Last Updated: 2016-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2012-10-31
2015-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cohort 1
Gemcitabine
1500 mg/m\^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
Docetaxel
50 mg/m\^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
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.
Interventions
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Gemcitabine
1500 mg/m\^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
Docetaxel
50 mg/m\^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
University of Vermont
OTHER
Responsible Party
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Claire Verschraegen
Director, Hematology Oncology Unit
Locations
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Fletcher Allen Health Care
Burlington, Vermont, United States
Countries
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Other Identifiers
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VCC 1202
Identifier Type: -
Identifier Source: org_study_id
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