Trial | NCT00737867  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    444
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.
Study Started
Sep 30
2007
Primary Completion
Feb 28
2011
Study Completion
Feb 28
2011
Last Update
Apr 04
2011
Estimate

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

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)

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

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

Criteria 

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
No Results Posted