Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2011 by Soroka University Medical Center
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01333631
First received: March 27, 2011
Last updated: April 10, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Valproic acid
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: Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Gemcitabine for Unresectable Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Number of the patients with side effects [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of the patients survived [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valporoic acid + chemoradiotherapy Drug: Valproic acid
Valproic acid given concurrent with chemoradiotherapy for patients with pancreatic cancer

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01333631

Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Konstantin Lavrenkov, MD, PhD Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Dr. Konstantin lavrenkov, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01333631     History of Changes
Other Study ID Numbers: SOR513511CTIL
Study First Received: March 27, 2011
Last Updated: April 10, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Locally advanced unresectable pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 18, 2014