Vinorelbine/Gemcitabine Verses Vinorelbine/Carboplatin in Advanced Non-Small Cell Lung Cancer

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Vinorelbine/Gemcitabine Verses Vinorelbine/Carboplatin in Advanced Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by The Norwegian Lung Cancer Study Group, August 2008
Sponsored by: The Norwegian Lung Cancer Study Group

Information provided by: The Norwegian Lung Cancer Study Group
ClinicalTrials.gov Identifier: NCT00737867

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 III




MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy
Drug Information available for: Carboplatin Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)


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


Primary Outcome Measures:
survival [ Time Frame: one year ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
Health related quality of life (HrQoL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Need for palliative radiotherapy [ Time Frame: one year ] [ Designated as safety issue: No ]


Estimated Enrollment: 444
Study Start Date: September 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
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
Drug: Gemcitabine
Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2
B: Active Comparator
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
Drug: Carboplatin
Day 1: Carboplatin infusion AUC = 5 (Calvert`s formula)



Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737867


Contacts
Contact: Øystein Fløtten, MD 55973245 ext +47 oystein.flotten@helse-bergen.no


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

Sponsors and Collaborators
The Norwegian Lung Cancer Study Group
Investigators
Study Chair: Øystein Fløtten Haukeland University Hospital, thoracic department

More Information

Responsible Party: Haukeland University Hospital ( Øystein Fløtten )
Study ID Numbers: 11066741577, Eudra-CT-nr 2006-002927-18
Study First Received: August 19, 2008
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00737867 [history]
Health Authority: Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services

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



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carboplatin
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic



ClinicalTrials.gov processed this record on February 10, 2009


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