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Non-small-cell Lung CancerPhase 3NCT00442026

Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

A Phase 3 study testing Docetaxel and Gemcitabine in people with Non-small-cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC Read more about this study

Who is it for?
Ages 70 to 85 years
Conditions the study is for
Non-small-cell Lung Cancer
What is being tested?
Docetaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
9 sitesGreece
Study dates
Dec 2006to May 2010
Phase
Phase 3
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 70 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
  • Stage IIIB/IV
  • No prior chemotherapy
  • Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
  • Absence or irradiated and stable central nervous system metastatic disease
  • Life expectancy of more than 3 months
Show all 13Show fewer
  • Age ≥ 70 years.
  • Performance status (WHO) < 3
  • Patients "non-frail" according to comprehensive geriatric assessment
  • Adequate bone marrow function (Absolute neutrophil count > 1000/mm^3, Platelet count > 100000/mm^3, Hemoglobin > 9gr/mm^3).
  • Adequate liver (Bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl).
  • Adequate cardiac function (LVEF > 50%).
  • Informed consent.

Who cannot join

  • Psychiatric illness or social situation that would preclude study compliance.
  • Other concurrent uncontrolled illness.
  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
  • No presence of a reliable care giver
  • Other concurrent investigational agents.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Greece9 sites

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology

    Alexandroupoli

  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

    Athens

  • 401 Military Hospital, Medical Oncology Unit

    Athens

  • Air Forces Military Hospital, Dep of Medical Oncology

    Athens

  • IASO" General Hospital of Athens, 1st Dep of Medical Oncology

    Athens

  • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

    Athens

  • Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

    Athens

  • "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

    Piraeus

  • Theagenion" Anticancer Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Official title: A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC

Read the detailed description

Docetaxel and gemcitabine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation

Being tested
Docetaxel, Gemcitabine
Keywords
Cancer, NSCLC, Elderly, Chemotherapy, Docetaxel, Gemcitabine
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

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

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine at the dose of 1200mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Study groups in NCT00442026
Study groupRoleWhat they receive
1ExperimentalDG
Receives: Drug: Docetaxel; Drug: Gemcitabine
2ExperimentalG
Receives: Drug: Gemcitabine

What is being measured

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

  1. Overall survival between the two treatment arms

    Measured: Probability of 1 year survival (%)

Secondary outcomes (4)

  1. Overall response rate

    Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

  2. Time to disease progression

    Measured: 1 year

  3. Quality of life assessment

    Measured: Assessment every two cycles

  4. Toxicity profile

    Measured: Assessment every two cycles

Timeline

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

  1. First posted1 Mar 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionMay 2010
  4. Study completionMay 2010

Why it stopped: Due to poor accrual

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00442026
Sponsor's protocol ID
CT/06.11
Status last verified
Jun 2012
First submitted
28 Feb 2007
Last updated
27 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Karampeazis A, Vamvakas L, Kotsakis A, Christophyllakis C, Kentepozidis N, Chandrinos V, Agelidou A, Polyzos A, Tsiafaki X, Hatzidaki D, Georgoulias V. Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment: Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study. J Geriatr Oncol. 2017 Jan;8(1):23-30. doi: 10.1016/j.jgo.2016.05.002. Epub 2016 Jun 2.

    PubMed 27264267

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel and Gemcitabine in people with Non-small-cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.

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 13 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Greece. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: Due to poor accrual). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival between the two treatment arms (time frame: Probability of 1 year survival (%)). 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 NCT00442026, which also lists 1 linked publication.

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 27 Jun 2012.

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