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

Primary Purpose

Advanced Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Vinorelbine
Gemcitabine
Vinorelbine
Carboplatin
Sponsored by
The Norwegian Lung Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-Small Cell Lung Cancer focused on measuring lung cancer, chemotherapy, vinorelbine, gemcitabine, carboplatin, advanced lung cancer, non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Øystein Fløtten
  • Sverre Fluge
  • Heidi Rolke
  • Tore Amundsen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

survival

Secondary Outcome Measures

Health related quality of life (HrQoL)
Toxicity
Need for palliative radiotherapy

Full Information

First Posted
August 19, 2008
Last Updated
April 1, 2011
Sponsor
The Norwegian Lung Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00737867
Brief Title
Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Norwegian Lung Cancer Study Group

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-Small Cell Lung Cancer
Keywords
lung cancer, chemotherapy, vinorelbine, gemcitabine, carboplatin, advanced lung cancer, non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
444 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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
Arm Title
B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine® Oral
Intervention Description
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar, Gemcitabin
Intervention Description
Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine® Oral
Intervention Description
Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Day 1: Carboplatin infusion AUC = 5 (Calvert's formula)
Primary Outcome Measure Information:
Title
survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
Health related quality of life (HrQoL)
Time Frame
3 months
Title
Toxicity
Time Frame
3 months
Title
Need for palliative radiotherapy
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øystein Fløtten
Organizational Affiliation
Haukeland University Hospital, thoracic department
Official's Role
Study Chair
Facility Information:
Facility Name
Øystein Fløtten
City
Bergen
ZIP/Postal Code
5000
Country
Norway
Facility Name
Sverre Fluge
City
Haugesund
ZIP/Postal Code
7000
Country
Norway
Facility Name
Heidi Rolke
City
Kristiansand
Country
Norway
Facility Name
Tore Amundsen
City
Trondheim
ZIP/Postal Code
7000
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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