Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer
This study has been completed.
Sponsor:
The Norwegian Lung Cancer Study Group
Information provided by:
The Norwegian Lung Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00737867
First received: August 19, 2008
Last updated: April 1, 2011
Last verified: April 2011
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
Drug Information available for:
Carboplatin
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
U.S. FDA Resources
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 |
| 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:
|
|
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)
Other Name: Carboplatin
|
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
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
No publications provided
| 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 |
| Study First Received: | August 19, 2008 |
| Last Updated: | April 1, 2011 |
| 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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Vinorelbine Vinblastine Carboplatin Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 19, 2013