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

April 1, 2011 updated by: The Norwegian Lung Cancer Study Group

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

444

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5000
        • Øystein Fløtten
      • Haugesund, Norway, 7000
        • Sverre Fluge
      • Kristiansand, Norway
        • Heidi Rolke
      • Trondheim, Norway, 7000
        • Tore Amundsen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: 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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life (HrQoL)
Time Frame: 3 months
3 months
Toxicity
Time Frame: 3 months
3 months
Need for palliative radiotherapy
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Norwegian Lung Cancer Study Group

Investigators

  • Study Chair: Øystein Fløtten, Haukeland University Hospital, thoracic department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11066741577
  • Eudra-CT-nr 2006-002927-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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