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

NCT ID: NCT01203735

Last Updated: 2011-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Valproic acid, Chemoradiotherapy

Group Type: OTHER

Valproic acid

Intervention Type: DRUG

800mg per day for entire period of RT

Interventions

Valproic acid

800mg per day for entire period of RT

Intervention Type: DRUG

Other Intervention Names

Sodium valproate

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Department of Oncology, Soroka University Medical Center

Principal Investigators

Konstantin Lavrenkov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

Soroka University Medical Center

Beersheba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Konstantin Lavrenkov, MD, PhD

Role: CONTACT

constant@bgu.ac.il

972-86400537

Facility Contacts

Konstantin Lavrenkov, MD, PhD

Role: primary

constant@bgu.ac.il

+97286400537

Julia Dudnik, MD

Role: backup

juliad@clalit.org.il

+97286400537

Other Identifiers

SOR507910CTIL

Identifier Type: -

Identifier Source: org_study_id