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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Keywords

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Cancer Elderly Chemotherapy Docetaxel Vinorelbine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

D

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

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

2

V

Group Type EXPERIMENTAL

Vinorelbine

Intervention Type DRUG

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

Interventions

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Docetaxel

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

Intervention Type DRUG

Vinorelbine

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

Intervention Type DRUG

Other Intervention Names

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Taxotere Navelbine

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hellenic Oncology Research Group

Principal Investigators

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Lampros Vamvakas, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete, Department of Medical Oncology

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CT/03.07

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Docetaxel

2

Vinorelbine

Interventions

Docetaxel

Vinorelbine

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University Hospital of Crete

Hellenic Oncology Research Group

Responsible Party

Principal Investigators

Lampros Vamvakas, MD

Locations

University General Hospital of Alexandroupolis, Department of Medical Oncology

401 Military Hospital of Athens

Air Forces Military Hospital of Athens

IASO General Hospital of Athens, 1st Department of Medical Oncology

Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine

Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases

Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases

State General Hospital of Larissa, Department of Medical Oncology

Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology

Theagenion Anticancer Hospital of Thessaloniki

Countries

Other Identifiers

CT/03.07