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Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas

NCT01106872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2018-08-10

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Bevacizumab, Gemcitabine, Docetaxel and Valproic Acid

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Mohammed M Milhem

    lead OTHER

Principal Investigators

  • Mohammed Milhem, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2017-07-31
Completion
2017-08-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106872 on ClinicalTrials.gov