Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer
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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 |
- Toxicity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- 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 |
Inclusion Criteria:
- Age > 18 years.
- Newly-diagnosed, histologically or cytologically confirmed NSCLC.
- Inoperable stage IIIA-B disease
- KPS > 60
- FEV1 >1.2L
- No previous RT to chest
- No serious comorbid condition
- No treatment with biological response modifiers or cytotoxic agents within four weeks prior to study entry
- 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, 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
- Ability to sign informed consent
- Ability to attend follow-up visits
Exclusion Criteria:
- Operable disease
- Metastases to contra-lateral mediastinal lymph nodes
- Distant metastases
- KPS < 60
- FEV1 < 1.2L
- Previous RT to chest
- Treatment with biological response modifiers or cytotoxic agents 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 Version 1, May 12, 2010 Calcium > ULN
- Inability to sign informed consent
- Psychological, familial, sociological or geographical conditions which do not permit regular medical follow-up and compliance with the protocol
Contacts and Locations| Contact: Konstantin Lavrenkov, MD, PhD | 972-86400537 | constant@bgu.ac.il |
| 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 | |
| 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Valproic Acid Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013