Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer
NCT ID: NCT00441740
Last Updated: 2008-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
419 participants
INTERVENTIONAL
2004-04-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
VG
Vinorelbine
Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
Gemcitabine
Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
2
DG
Docetaxel
Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
Gemcitabine
Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
Interventions
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Vinorelbine
Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
Gemcitabine
Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Docetaxel
Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
Gemcitabine
Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous therapy for advanced/metastatic NSCLC is allowed
* Age \> 18 years
* Bidimensionally measurable disease
* Performance status (WHO) 0-2
* Adequate liver (serum bilirubin \< 1.5 times the upper normal limit (UNL); AST and ALT \< 2.5 times the UNL in the absence of demonstrable liver metastases, or \< 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \< 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
* Life expectancy of more than 3 months
* Patient able to take oral medication
* At least 4 weeks since prior radiotherapy
* Written informed consent
Exclusion Criteria
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Malnutrition (loss of ≥ 20% of the original body weight)
* Performance status: 3-4
* Sensor or motor neuropathy \> grade I
* Second primary malignancy, except for non-melanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
* Known, symptomatic central nervous system metastases
18 Years
75 Years
ALL
No
Sponsors
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University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
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Hellenic Oncology Research Group
Principal Investigators
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Vassilis Georgoulias, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Crete, Dep of Medical Oncology
Locations
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University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, , Greece
" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, , Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, , Greece
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Athens, , Greece
401 Military Hospital, Medical Oncology Unit
Athens, , Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, , Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, , Greece
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens, , Greece
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Countries
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Other Identifiers
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CT/04.04
Identifier Type: -
Identifier Source: org_study_id