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Valproic Acid With Chemoradiotherapy for Pancreatic Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

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

NCT01333631•Soroka University Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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:
+10 more criteria

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 more criteria

Key Dates

Start Date

June 1, 2011

Primary Completion Date

June 1, 2013

Completion Date

July 1, 2015

Last Updated

April 12, 2011

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

Valproic acid

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Resilience and Equity in Aging, Cancer, and Health (REACH)

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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

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