Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Vinorelbine; Drug: Docetaxel

• Registration Number: NCT00441922
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

This trial will compare the efficacy of docetaxel versus vinorelbine as first-line treatment in elderly patients with advanced NSCLC.

Detailed Description

Docetaxel and vinorelbine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-28
• Last Update Posted: 2008-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
• Stage IIIB/IV
• No prior chemotherapy
• Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated
• Life expectancy of more than 3 months
• Age ≥ 65 years
• Performance status (WHO) ≤ 3
• Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, Hemoglobin > 9 gr/mm^3)
• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
• Informed consent

Exclusion Criteria

• Psychiatric illness or social situation that would preclude study compliance.
• Other concurrent uncontrolled illness
• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No absence or irradiated and stable central nervous system metastatic disease.
• No presence of a reliable care giver
• Other concurrent investigational agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Vinorelbine	V
1	Docetaxel	D

Primary Outcome Measures

Name	Time	Method
Overall survival between the two treatment arms	1 year

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	1 year
Toxicity profile	During the time of chemotherapy

Trial Locations

Locations (10)

Theagenion Anticancer Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

University General Hospital of Alexandroupolis, Department of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

IASO General Hospital of Athens, 1st Department of Medical Oncology; 🇬🇷 Athens, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine; 🇬🇷 Athens, Greece

Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases; 🇬🇷 Athens, Greece

Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases; 🇬🇷 Athens, Greece

State General Hospital of Larissa, Department of Medical Oncology; 🇬🇷 Larissa, Greece

Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology; 🇬🇷 Piraeus, Greece