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

Sponsor
The Norwegian Lung Cancer Study Group (Other)
Overall Status
Completed
CT.gov ID
NCT00737867
Collaborator
(none)
444
Enrollment
4
Locations
2
Arms
41
Duration (Months)
111
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
444 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Vinorelbine
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
Other Names:
  • Navelbine® Oral

    • Drug: Gemcitabine
    Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
    Other Names:
  • Gemzar
  • Gemcitabin

    		•
    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

    Drug: Vinorelbine
    Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
    Other Names:
  • Navelbine® Oral

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

    Outcome Measures

    Primary Outcome Measures

    1. survival [one year]

    Secondary Outcome Measures

    1. Health related quality of life (HrQoL) [3 months]

    2. Toxicity [3 months]

    3. Need for palliative radiotherapy [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Øystein Fløtten Bergen Norway 5000
    2 Sverre Fluge Haugesund Norway 7000
    3 Heidi Rolke Kristiansand Norway
    4 Tore Amundsen Trondheim Norway 7000

    Sponsors and Collaborators

    • The Norwegian Lung Cancer Study Group

    Investigators

    • Study Chair: Øystein Fløtten, Haukeland University Hospital, thoracic department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00737867
    Other Study ID Numbers:
    • 11066741577
    • Eudra-CT-nr 2006-002927-18
    First Posted:
    Aug 20, 2008
    Last Update Posted:
    Apr 4, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    lung cancer
    chemotherapy
    vinorelbine
    gemcitabine
    carboplatin
    advanced lung cancer
    non-small cell lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Gemcitabine
    Carboplatin
    Vinorelbine

    Study Results

    No Results Posted as of Apr 4, 2011