Status:
COMPLETED
Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients w...
Detailed Description
Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
- 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
- Active infection
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00441740
Start Date
April 1 2004
End Date
February 1 2008
Last Update
October 31 2008
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Athens, Greece