Clinical trial NCT00441922: Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC)
Official title: A Multicenter Randomized Phase II Study of Docetaxel Versus Vinorelbine as First-Line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: Cancer
Elderly
Chemotherapy
Docetaxel
Vinorelbine
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-03-01
Enrollment: 166
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival between the two treatment arms
timeFrame: 1 year
Secondary outcomes:
measure: Time to disease progression
timeFrame: 1 year
measure: Toxicity profile
timeFrame: During the time of chemotherapy
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Department of Medical Oncology
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Athens
country: Greece
facility: IASO General Hospital of Athens, 1st Department of Medical Oncology
city: Athens
country: Greece
facility: Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
city: Athens
country: Greece
facility: Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
city: Athens
country: Greece
facility: Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases
city: Larissa
country: Greece
facility: State General Hospital of Larissa, Department of Medical Oncology
city: Piraeus
country: Greece
facility: Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
city: Thessaloniki
country: Greece
facility: Theagenion Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Crete, Department of Medical Oncology
name: Lampros Vamvakas, MD
role: PRINCIPAL_INVESTIGATOR
References: