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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)


Phase 3
65 Years
80 Years
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival between the two treatment arms

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Lampros Vamvakas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Department of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/03.07

NCT ID:

NCT00441922

Start Date:

January 2003

Completion Date:

January 2008

Related Keywords:

  • Non Small Cell Lung Cancer
  • Cancer
  • Elderly
  • Chemotherapy
  • Docetaxel
  • Vinorelbine
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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