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Non Small Cell Lung CancerPhase 3NCT00441740

Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Vinorelbine, Gemcitabine and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
419 participants
Where
9 sitesGreece
Study dates
Apr 2004to Feb 2008
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
  • No previous therapy for advanced/metastatic NSCLC is allowed
  • Age > 18 years
  • Bidimensionally measurable disease
  • Performance status (WHO) 0-2
  • Adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
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  • Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
  • Life expectancy of more than 3 months
  • Patient able to take oral medication
  • At least 4 weeks since prior radiotherapy
  • Written informed consent

Who cannot join

  • Active infection
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • Malnutrition (loss of ≥ 20% of the original body weight)
  • Performance status: 3-4
  • Sensor or motor neuropathy > grade I
  • Second primary malignancy, except for non-melanoma skin cancer
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  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women
  • Known, symptomatic central nervous system metastases

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

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

    Athens

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

    Athens

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

    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

  • "Theagenion" Anticancer Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

About this study

Official title: Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Read the detailed description

Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.

Keywords
NSCLC, 1st line treatment, Gemcitabine, Vinorelbine, Docetaxel
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.

  • VinorelbineDrug

    Also called Navelbine

    Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles

Study groups in NCT00441740
Study groupRoleWhat they receive
1ExperimentalVG
Receives: Drug: Vinorelbine; Drug: Gemcitabine
2ExperimentalDG
Receives: Drug: Docetaxel; Drug: Gemcitabine

What is being measured

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

  1. Overall survival

    Measured: 1 year

Secondary outcomes (4)

  1. Response rate

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

  2. Time to tumor progression

    Measured: 1 year

  3. Toxicity

    Measured: Toxicity assessment on each chemotherapy cycle

  4. Quality of life

    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 startApr 2004
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

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
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00441740
Sponsor's protocol ID
CT/04.04
Status last verified
Oct 2008
First submitted
28 Feb 2007
Last updated
31 Oct 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vinorelbine, Gemcitabine and Docetaxel 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 31 Oct 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: 1 year). 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 NCT00441740.

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 31 Oct 2008.

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