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

Advanced Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737867
• Other study ID #: 11066741577
• Secondary ID: Eudra-CT-nr 2006
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2008
• Last updated: April 1, 2011
• Start date: September 2007
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: The Norwegian Lung Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Norway	Øystein Fløtten	Bergen
Norway	Sverre Fluge	Haugesund
Norway	Heidi Rolke	Kristiansand
Norway	Tore Amundsen	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
The Norwegian Lung Cancer Study Group

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival		one year	No
Secondary	Health related quality of life (HrQoL)		3 months	No
Secondary	Toxicity		3 months	No
Secondary	Need for palliative radiotherapy		one year	No