NCT00737867

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2007

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 4, 2011

Status Verified

April 1, 2011

Enrollment Period

3.4 years

First QC Date

August 19, 2008

Last Update Submit

April 1, 2011

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

lung cancerchemotherapyvinorelbinegemcitabinecarboplatinadvanced lung cancernon-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • survival

    one year

Secondary Outcomes (3)

  • Health related quality of life (HrQoL)

    3 months

  • Toxicity

    3 months

  • Need for palliative radiotherapy

    one year

Study Arms (2)

A

EXPERIMENTAL

Day 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

Drug: VinorelbineDrug: Gemcitabine

B

ACTIVE COMPARATOR

Day 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

Drug: VinorelbineDrug: Carboplatin

Interventions

VinorelbineDRUG

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

Also known as: Navelbine® Oral
A
GemcitabineDRUG

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

Also known as: Gemzar, Gemcitabin
A
CarboplatinDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Øystein Fløtten

Bergen, 5000, Norway

Location

Sverre Fluge

Haugesund, 7000, Norway

Location

Heidi Rolke

Kristiansand, Norway

Location

Tore Amundsen

Trondheim, 7000, Norway

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

VinorelbineGemcitabineCarboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Øystein Fløtten

    Haukeland University Hospital, thoracic department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

September 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 4, 2011

Record last verified: 2011-04

Locations

NO(4)