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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Docetaxel
Vinorelbine
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Cancer, Elderly, Chemotherapy, Docetaxel, Vinorelbine

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept 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

Sites / 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

D

V

Outcomes

Primary Outcome Measures

Overall survival between the two treatment arms

Secondary Outcome Measures

Time to disease progression
Toxicity profile

Full Information

First Posted
February 28, 2007
Last Updated
October 28, 2008
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00441922
Brief Title
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Cancer, Elderly, Chemotherapy, Docetaxel, Vinorelbine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
D
Arm Title
2
Arm Type
Experimental
Arm Description
V
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel at the dose of 38 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Description
Vinorelbine at the dose of 25 mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
Primary Outcome Measure Information:
Title
Overall survival between the two treatment arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to disease progression
Time Frame
1 year
Title
Toxicity profile
Time Frame
During the time of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lampros Vamvakas, MD
Organizational Affiliation
University Hospital of Crete, Department of Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Department of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
IASO General Hospital of Athens, 1st Department of Medical Oncology
City
Athens
Country
Greece
Facility Name
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
City
Athens
Country
Greece
Facility Name
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
Sotiria General Hospital, 1st, 3rd, 8th Department of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa, Department of Medical Oncology
City
Larissa
Country
Greece
Facility Name
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
Theagenion Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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