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

Sponsor

Hellenic Oncology Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00441922

Collaborator

University Hospital of Crete (Other)

166

Enrollment

Locations

Arms

Duration (Months)

16.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Docetaxel Drug: Vinorelbine	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 D	Drug: Docetaxel Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles Other Names: Taxotere
Experimental: 2 V	Drug: Vinorelbine Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles Other Names: Navelbine

Arm

Intervention/Treatment

Experimental: 1

Drug: Docetaxel

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

Other Names:

Taxotere

Experimental: 2

Drug: Vinorelbine

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

Other Names:

Navelbine

Outcome Measures

Primary Outcome Measures

Overall survival between the two treatment arms [1 year]

Secondary Outcome Measures

Time to disease progression [1 year]
Toxicity profile [During the time of chemotherapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	University General Hospital of Alexandroupolis, Department of Medical Oncology	Alexandroupolis	Greece
2	401 Military Hospital of Athens	Athens	Greece
3	Air Forces Military Hospital of Athens	Athens	Greece
4	IASO General Hospital of Athens, 1st Department of Medical Oncology	Athens	Greece
5	Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine	Athens	Greece
6	Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases	Athens	Greece
7	Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases	Athens	Greece
8	State General Hospital of Larissa, Department of Medical Oncology	Larissa	Greece
9	Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology	Piraeus	Greece
10	Theagenion Anticancer Hospital of Thessaloniki	Thessaloniki	Greece