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