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

Non Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441922
• Other study ID #: CT/03.07
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2007
• Last updated: October 28, 2008
• Start date: January 2003
• Est. completion date: January 2008

Study information

• Verified date: October 2008
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Docetaxel
Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
• Vinorelbine
Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Department of Medical Oncology	Alexandroupolis
Greece	401 Military Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	IASO General Hospital of Athens, 1st Department of Medical Oncology	Athens
Greece	Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine	Athens
Greece	Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases	Athens
Greece	Sotiria General Hospital, 1st, 3rd, 8th 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	Theagenion Anticancer Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival between the two treatment arms		1 year	No
Secondary	Time to disease progression		1 year	No
Secondary	Toxicity profile		During the time of chemotherapy	Yes