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Clinical Trial Record

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Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

2011-06

2013-06

2015-07

20

Study Overview

Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

This is non-randomized phase 2 study to evaluate toxicity and efficacy of valproic acid (VA) with concurrent chemoradiotherapy (CCRT) containing weekly gemcitabine in patients with unresectable locally advanced pancreatic cancer (ULAPC). All patients will be planned for three-dimensional conformal radiotherapy (3-DCRT). A total dose of 54 Gy will be delivered using 2 Gy daily fractions given over 5 days a week.Intravenous (i.v.) chemotherapy (ChT) with gemcitabine 300 mg/m2 will be started at the first day of 3-DCRT.Total 5-6 weekly doses of i.v. ChT will be planned.VA will be administered orally in daily dose of 800 mg. Treatment with VA will be commenced at the first day and will be terminated at last day of RT.The patients will be followed till disease progression or death.

N/A

  • Pancreatic Cancer
  • DRUG: Valproic acid
  • SOR513511CTIL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2011-03-27  

N/A  

2011-04-10  

2011-04-10  

N/A  

2011-04-12  

2011-04-12  

N/A  

2011-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Valporoic acid + chemoradiotherapy

DRUG: Valproic acid

  • Valproic acid given concurrent with chemoradiotherapy for patients with pancreatic cancer
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of the patients with side effects2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Number of the patients survived2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Age > 18 years. 2. Newly-diagnosed, histologically/cytologically or CA 19.9 confirmed ULAPC 3. KPS > 60 4. No previous RT to abdomen 5. No serious comorbid condition Version 1, December 1, 2010 6. No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry, apart from induction chemotherapy with gemcitabine 7. No participation in clinical trial using any investigational drug or device within four weeks prior to study entry 8. No serious complication of malignant condition 9. No previous or concurrent malignancy at other sites except cone biopsied in situ carcinoma of the uterine cervix and adequately treated basal cell or squamous cell carcinoma of the skin 10. Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

  • Hemoglobin > 9.0 Gm/dL
  • WBC count > 4.0x109/L
  • Neutrophile count > 1.5 cells x 109/L,
  • Platelet count > 100 x 109/L,
  • Creatinine < 1.5 mg/dL
  • Total bilirubin < upper limit of normal (ULN)
  • AST/SGOT < ULN
  • Calcium < ULN 11. Ability to sign informed consent 12. Ability to attend follow-up visits

    • Exclusion Criteria:
    1. Operable disease 2. Distant metastases 3. KPS < 60 4. Previous RT to abdomen 5. Treatment with biological response modifiers or cytotoxic agents other then induction gemcitabine within four weeks prior to study entry 6. Participation in clinical trial using any investigational drug or device within four weeks prior to study entry 7. Major surgical procedure within two weeks prior to study entry 8. Serious comorbid condition, inclusive but not limited to myocardial infarction within previous six months, uncontrolled cardiac arrhythmias, uncontrolled angina pectoris, active infection including acute hepatitis 9. Serious complication of malignant condition 10. Previous or concurrent malignancy 11. Inadequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

  • Hemoglobin < 9.0 Gm/dL
  • WBC count < 4.0x109/L
  • Neutrophile count < 1.5 cells x 109/L,
  • Platelet count < 100 x 109/L,
  • Creatinine > 1.5 mg/dL
  • Total bilirubin > ULN (upper limit of normal)
  • AST/SGOT > ULN
  • Calcium > ULN 12. Inability to sign informed consent 13. Psychological, familial, sociological or geographical conditions which do permit regular medical follow-up and compliance with the protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Konstantin Lavrenkov, MD, PhD, Soroka University Medical Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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    The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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