Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Gemcitabine for Unresectable Locally Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Valproic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Newly-diagnosed, histologically/cytologically or CA 19.9 confirmed ULAPC KPS > 60 No previous RT to abdomen No serious comorbid condition Version 1, December 1, 2010 No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry, apart from induction chemotherapy with gemcitabine No participation in clinical trial using any investigational drug or device within four weeks prior to study entry No serious complication of malignant condition 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 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 Ability to sign informed consent Ability to attend follow-up visits Exclusion Criteria: Operable disease Distant metastases KPS < 60 Previous RT to abdomen Treatment with biological response modifiers or cytotoxic agents other then induction gemcitabine within four weeks prior to study entry Participation in clinical trial using any investigational drug or device within four weeks prior to study entry Major surgical procedure within two weeks prior to study entry 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 Serious complication of malignant condition Previous or concurrent malignancy 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 Inability to sign informed consent Psychological, familial, sociological or geographical conditions which do permit regular medical follow-up and compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valporoic acid + chemoradiotherapy<br> | Drug: Valproic acid<br>* Valproic acid given concurrent with chemoradiotherapy for patients with pancreatic cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the patients with side effects |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the patients survived |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced unresectable pancreatic cancer