Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer
NCT ID: NCT00737867
Last Updated: 2011-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
444 participants
INTERVENTIONAL
2007-09-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Vinorelbine
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
Gemcitabine
Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
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
Vinorelbine
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
Carboplatin
Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)
Interventions
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Vinorelbine
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
Gemcitabine
Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
Vinorelbine
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
Carboplatin
Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not eligible for radical radiotherapy or surgery
* WHO performance status 0-2
Exclusion Criteria
* Other clinical active cancer disease
* ALAT/ALP more than 3 times upper normal limit, bilirubin \>1.5 upper limit
* Bowel disease that causes malabsorption
18 Years
ALL
No
Sponsors
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The Norwegian Lung Cancer Study Group
NETWORK
Responsible Party
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Haukeland University Hospital
Principal Investigators
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Øystein Fløtten
Role: STUDY_CHAIR
Haukeland University Hospital, thoracic department
Locations
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Øystein Fløtten
Bergen, , Norway
Sverre Fluge
Haugesund, , Norway
Heidi Rolke
Kristiansand, , Norway
Tore Amundsen
Trondheim, , Norway
Countries
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Other Identifiers
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Eudra-CT-nr 2006-002927-18
Identifier Type: -
Identifier Source: secondary_id
11066741577
Identifier Type: -
Identifier Source: org_study_id
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