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Advanced Non-Small Cell Lung CancerPhase 3NCT00737867

Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

A Phase 3 study testing Vinorelbine, Gemcitabine and Carboplatin in people with Advanced Non-Small Cell Lung Cancer, run by The Norwegian Lung Cancer Study Group at 4 sites in Norway.

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 explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
Vinorelbine, Gemcitabine and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
4 sitesNorway
Study dates
Sep 2007to Feb 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-small cell lung cancer stage IIIB or IV
  • Not eligible for radical radiotherapy or surgery
  • WHO performance status 0-2

Who cannot join

  • Pregnancy
  • Other clinical active cancer disease
  • ALAT/ALP more than 3 times upper normal limit, bilirubin >1.5 upper limit
  • Bowel disease that causes malabsorption

Trial locations and contacts

4 sites in 1 country.

Norway4 sites

  • Øystein Fløtten

    Bergen, 5000

  • Sverre Fluge

    Haugesund, 7000

  • Heidi Rolke

    Kristiansand

  • Tore Amundsen

    Trondheim, 7000

Other trials in Norway

About this study

Official title: Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG)

The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.

Keywords
lung cancer, chemotherapy, vinorelbine, gemcitabine, carboplatin, advanced lung cancer, non-small cell lung cancer
Medical subject headings
Lung Neoplasms, 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® Oral

    Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2

  • GemcitabineDrug

    Also called Gemzar, Gemcitabin

    Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2

  • VinorelbineDrug

    Also called Navelbine® Oral

    Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2

  • CarboplatinDrug

    Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)

Study groups in NCT00737867
Study groupRoleWhat they receive
AExperimentalDay 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Gemcitabine infusion 1000 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks
Receives: Drug: Vinorelbine; Drug: Gemcitabine
BActive comparatorDay 1: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 + Carboplatin infusion AUC = 5 (Calvert's formula) Day 8: Vinorelbine (Navelbine® Oral) capsules 60 mg/m2 All patients will receive a maximum of 3 courses with an interval of 3 weeks
Receives: Drug: Vinorelbine; Drug: Carboplatin

What is being measured

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

  1. survival

    Measured: one year

Secondary outcomes (3)

  1. Health related quality of life (HrQoL)

    Measured: 3 months

  2. Toxicity

    Measured: 3 months

  3. Need for palliative radiotherapy

    Measured: one year

Timeline

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

  1. First posted20 Aug 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

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
444 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00737867
Sponsor's protocol ID
11066741577
Other IDs
Eudra-CT-nr 2006-002927-18
Status last verified
Apr 2011
First submitted
19 Aug 2008
Last updated
4 Apr 2011
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 Carboplatin in people with Advanced Non-Small Cell Lung Cancer, run by The Norwegian Lung Cancer Study Group at 4 sites in Norway.

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 3 inclusion and 4 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 4 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway. 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?

survival (time frame: one 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 NCT00737867.

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 4 Apr 2011.

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