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

This study has been completed.
Sponsor:
Information provided by:
The Norwegian Lung Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00737867
First received: August 19, 2008
Last updated: April 1, 2011
Last verified: April 2011
History of Changes

August 19, 2008
April 1, 2011
September 2007
February 2011   (final data collection date for primary outcome measure)
survival [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00737867 on ClinicalTrials.gov Archive Site
  • Health related quality of life (HrQoL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Need for palliative radiotherapy [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Non-Small Cell Lung Cancer
  • Drug: Vinorelbine
    Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
    Other Name: Navelbine® Oral
  • Drug: Gemcitabine
    Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
    Other Names:
    • Gemzar
    • Gemcitabin
  • Drug: Carboplatin
    Day 1: Carboplatin infusion AUC = 5 (Calvert`s formula)
    Other Name: Carboplatin
  • Experimental: A

    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

    Interventions:
    • Drug: Vinorelbine
    • Drug: Gemcitabine
  • Active Comparator: B

    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

    Interventions:
    • Drug: Vinorelbine
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
444
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00737867
11066741577, Eudra-CT-nr 2006-002927-18
No
Øystein Fløtten, Haukeland University Hospital
The Norwegian Lung Cancer Study Group
Not Provided
Study Chair: Øystein Fløtten Haukeland University Hospital, thoracic department
The Norwegian Lung Cancer Study Group
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP