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

NCT01203735 | Unknown Phase 1

• 1 other identifier: SOR507910CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Inoperable Non-small-lung Cancer

Keywords

Non-small-cell lung cancer; Valproic acid; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Toxicity

  24 months

Secondary Outcomes (1)

• Survival

  24 months

Study Arms (1)

Valproic acid, Chemoradiotherapy

OTHER

Drug: Valproic acid

Interventions

Valproic acid DRUG

800mg per day for entire period of RT

Also known as: Sodium valproate

Valproic 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, 84101, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract 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

Central Study Contacts

Konstantin Lavrenkov, MD, PhD

CONTACT

972-86400537; constant@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2015
• Last Updated: March 29, 2011

Record last verified: 2010-09

Locations

IL (1)