Valproic Acid With Chemoradiotherapy for Pancreatic Cancer

NCT01333631 | Unknown Phase 2

• 1 other identifier: SOR513511CTIL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer

Keywords

Locally advanced unresectable pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Number of the patients with side effects

  2 years

Secondary Outcomes (1)

• Number of the patients survived

  2 years

Study Arms (1)

Valporoic acid + chemoradiotherapy

EXPERIMENTAL

Drug: Valproic acid

Interventions

Valproic acid DRUG

Valproic acid given concurrent with chemoradiotherapy for patients with pancreatic cancer

Valporoic acid + chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Konstantin Lavrenkov, MD, PhD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2011
• First Posted: April 12, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2015
• Last Updated: April 12, 2011

Record last verified: 2011-03