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Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Valproic acid

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Locally advanced unresectable pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valporoic acid + chemoradiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Number of the patients with side effects

Secondary Outcome Measures

Number of the patients survived

Full Information

NCT ID

NCT01333631

First Posted

March 27, 2011

Last Updated

April 10, 2011

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01333631

Brief Title

Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

July 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Soroka University Medical Center

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Locally advanced unresectable pancreatic cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Valporoic acid + chemoradiotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Valproic acid

Intervention Description

Valproic acid given concurrent with chemoradiotherapy for patients with pancreatic cancer

Primary Outcome Measure Information:

Title

Number of the patients with side effects

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Number of the patients survived

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Konstantin Lavrenkov, MD, PhD

Organizational Affiliation

Soroka University Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

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