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

Phase 3

Completed

• Conditions: Advanced Non-Small Cell Lung Cancer
• Interventions: Drug: Vinorelbine; Drug: Carboplatin; Drug: Gemcitabine

• Registration Number: NCT00737867
• Lead Sponsor: The Norwegian Lung Cancer Study Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Vinorelbine	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
A	Vinorelbine	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	Carboplatin	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
A	Gemcitabine	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

Primary Outcome Measures

Name	Time	Method
survival	one year

Secondary Outcome Measures

Name	Time	Method
Need for palliative radiotherapy	one year
Health related quality of life (HrQoL)	3 months
Toxicity	3 months

Trial Locations

Locations (4)

Øystein Fløtten; 🇳🇴 Bergen, Norway

Sverre Fluge; 🇳🇴 Haugesund, Norway

Tore Amundsen; 🇳🇴 Trondheim, Norway

Heidi Rolke; 🇳🇴 Kristiansand, Norway