Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Soroka University Medical Center
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01203735
First received: September 15, 2010
Last updated: March 27, 2011
Last verified: September 2010
  Purpose

This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with locally advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned for three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and oral valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3 months after completion of the study treatment. Toxicity will be assessed using CTCAE, based on clinical examination and laboratory tests during the study treatment and at follow up visits. Response to treatment will be evaluated using RECIST criteria. Overall and progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.


Condition Intervention Phase
Locally Advanced Inoperable Non-small-lung Cancer
Drug: Valproic acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Vinorelbine and Cisplatin for Inoperable Locally Advanced Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Valproic acid, Chemoradiotherapy Drug: Valproic acid
800mg per day for entire period of RT
Other Name: Sodium valproate

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years.
  2. Newly-diagnosed, histologically or cytologically confirmed NSCLC.
  3. Inoperable stage IIIA-B disease
  4. KPS > 60
  5. FEV1 >1.2L
  6. No previous RT to chest
  7. No serious comorbid condition
  8. No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
  9. No participation in clinical trial using any investigational drug or device within four weeks prior to study entry
  10. No serious complication of malignant condition
  11. 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
  12. 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, Version 1, May 12, 2010 Platelet count > 100 x 109/L, Creatinine < 1.5 mg/dL Total bilirubin < upper limit of normal (ULN) AST/SGOT < ULN Calcium < ULN

  13. Ability to sign informed consent
  14. Ability to attend follow-up visits

Exclusion Criteria:

  1. Operable disease
  2. Metastases to contra-lateral mediastinal lymph nodes
  3. Distant metastases
  4. KPS < 60
  5. FEV1 < 1.2L
  6. Previous RT to chest
  7. Treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
  8. Participation in clinical trial using any investigational drug or device within four weeks prior to study entry
  9. Major surgical procedure within two weeks prior to study entry
  10. 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
  11. Serious complication of malignant condition
  12. Previous or concurrent malignancy
  13. 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 Version 1, May 12, 2010 Calcium > ULN

  14. Inability to sign informed consent
  15. Psychological, familial, sociological or geographical conditions which do not permit regular medical follow-up and compliance with the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203735

Contacts
Contact: Konstantin Lavrenkov, MD, PhD 972-86400537 constant@bgu.ac.il

Locations
Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Contact: Konstantin Lavrenkov, MD, PhD    +97286400537    constant@bgu.ac.il   
Contact: Julia Dudnik, MD    +97286400537    juliad@clalit.org.il   
Sub-Investigator: Vladimir Gavrilov, MD, PhD         
Sub-Investigator: Julia Dudnik, MD         
Sub-Investigator: Kerenr Rouvinov, MD         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Konstantin Lavrenkov, MD, PhD Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Dr. Konstantin Lavrenkov, MD, PhD, Department of Oncology, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01203735     History of Changes
Other Study ID Numbers: SOR507910CTIL
Study First Received: September 15, 2010
Last Updated: March 27, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Non-small-cell lung cancer
Valproic acid
Chemotherapy
Radiotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014