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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737867
First Posted: August 20, 2008
Last Update Posted: April 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Norwegian Lung Cancer Study Group
  Purpose
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.

Condition Intervention Phase
Advanced Non-Small Cell Lung Cancer Drug: Vinorelbine Drug: Gemcitabine Drug: Carboplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by The Norwegian Lung Cancer Study Group:

Primary Outcome Measures:
  • survival [ Time Frame: one year ]

Secondary Outcome Measures:
  • Health related quality of life (HrQoL) [ Time Frame: 3 months ]
  • Toxicity [ Time Frame: 3 months ]
  • Need for palliative radiotherapy [ Time Frame: one year ]

Estimated Enrollment: 444
Study Start Date: September 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Navelbine® Oral
Drug: Carboplatin
Day 1: Carboplatin infusion AUC = 5 (Calvert`s formula)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737867


Locations
Norway
Øystein Fløtten
Bergen, Norway, 5000
Sverre Fluge
Haugesund, Norway, 7000
Heidi Rolke
Kristiansand, Norway
Tore Amundsen
Trondheim, Norway, 7000
Sponsors and Collaborators
The Norwegian Lung Cancer Study Group
Investigators
Study Chair: Øystein Fløtten Haukeland University Hospital, thoracic department
  More Information

Responsible Party: Øystein Fløtten, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00737867     History of Changes
Other Study ID Numbers: 11066741577
Eudra-CT-nr 2006-002927-18
First Submitted: August 19, 2008
First Posted: August 20, 2008
Last Update Posted: April 4, 2011
Last Verified: April 2011

Keywords provided by The Norwegian Lung Cancer Study Group:
lung cancer
chemotherapy
vinorelbine
gemcitabine
carboplatin
advanced lung cancer
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Vinorelbine
Carboplatin
Vinblastine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators