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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

March 27, 2011
April 10, 2011
June 2011
June 2013   (final data collection date for primary outcome measure)
Number of the patients with side effects [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01333631 on ClinicalTrials.gov Archive Site
Number of the patients survived [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Valproic Acid With Chemoradiotherapy for Pancreatic Cancer
Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Gemcitabine for Unresectable Locally Advanced 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Drug: Valproic acid
Valproic acid given concurrent with chemoradiotherapy for patients with pancreatic cancer
Experimental: Valporoic acid + chemoradiotherapy
Intervention: Drug: Valproic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
July 2015
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Not Provided
 
NCT01333631
SOR513511CTIL
Not Provided
Dr. Konstantin lavrenkov, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Konstantin Lavrenkov, MD, PhD Soroka University Medical Center
Soroka University Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP