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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of the patients with side effects

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Konstantin Lavrenkov, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Soroka University Medical Center

Authority:

Israel: Ministry of Health

Study ID:

SOR513511CTIL

NCT ID:

NCT01333631

Start Date:

June 2011

Completion Date:

July 2015

Related Keywords:

  • Pancreatic Cancer
  • Locally advanced unresectable pancreatic cancer
  • Pancreatic Neoplasms

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