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Locally Advanced Inoperable Non-small-lung CancerPhase 1/2NCT01203735

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

A Phase 1/2 study testing Valproic acid in people with Locally Advanced Inoperable Non-small-lung Cancer, run by Soroka University Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Valproic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteIsrael
Study dates
Feb 2011to Feb 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Operable disease
  • Metastases to contra-lateral mediastinal lymph nodes
  • Distant metastases
  • KPS < 60
  • FEV1 < 1.2L
  • Previous RT to chest
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Konstantin Lavrenkov, MD, PhD contact

972-86400537

constant@bgu.ac.il

Israel1 site, 1 recruiting

  • Soroka University Medical Center

    Beersheba, 84101

    Konstantin Lavrenkov, MD, PhD, +97286400537, constant@bgu.ac.il

    Julia Dudnik, MD, +97286400537, juliad@clalit.org.il

    Recruiting

Other trials in Israel

About this study

Official title: Valproic Acid in Combination With Concurrent Chemoradiotherapy Using Vinorelbine and Cisplatin for Inoperable Locally Advanced Non-Small-Cell Lung Cancer

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.

Being tested
Valproic acid
Keywords
Non-small-cell lung cancer, Valproic acid, Chemotherapy, Radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valproic acidDrug

    Also called Sodium valproate

    800mg per day for entire period of RT

Study groups in NCT01203735
Study groupRoleWhat they receive
Valproic acid, ChemoradiotherapyOtherNot described
Receives: Drug: Valproic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity

    Measured: 24 months

Secondary outcomes (1)

  1. Survival

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2013 (estimated)
  4. Study completionFeb 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01203735
Sponsor's protocol ID
SOR507910CTIL
Status last verified
Sep 2010
First submitted
15 Sep 2010
Last updated
29 Mar 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Valproic acid in people with Locally Advanced Inoperable Non-small-lung Cancer, run by Soroka University Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Konstantin Lavrenkov, MD, PhD (972-86400537, constant@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01203735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.

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