Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Mohammed M Milhem
Study ID
NCT01106872
Phase
PHASE1
Status
Completed

Conditions

  • Locally Advanced Sarcoma
  • Metastatic Sarcoma
  • Sarcoma
  • Soft Tissue Sarcoma
  • Unresectable Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to test the combination of the chemotherapy drugs Gemcitabine, bevacizumab, and docetaxel with valproic acid to treat patients with metastatic sarcoma. Valproic acid is used by people who have seizures to prevent seizures from happening; however, its use in cancer is investigational. This study will help define the proper dosing of this valproic acid. We will assess the safety of valproic acid with the combination of the above chemotherapy drugs and check for possible side effects. Valproic acid may improve the function of the chemotherapy drugs against the cancer.

Key Dates

First listed
Apr 20, 2010
Start date
Sep 30, 2010
Status verified
Aug 2018
Primary completion
Jul 31, 2017
Completion
Aug 22, 2017

Study Design

Enrollment
47 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Bevacizumab Combined with Gemcitabine, Docetaxel and Valproic Acid in Advanced Sarcoma

Primary Outcome Measure

Evaluate toxicities [ Time Frame: After one cycle (3 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52242-

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By research site
University of Iowa Hospitals and Clinics· Iowa City, IA

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