Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

Hellenic Oncology Research Group

Status and phase

Terminated

Phase 3

Conditions

Non-small-cell Lung Cancer

Treatments

Drug: Docetaxel

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00442026

CT/06.11

Details and patient eligibility

About

This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC

Full description

Docetaxel and gemcitabine 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. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation

Enrollment

106 patients

Sex

All

Ages

70 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
Stage IIIB/IV
No prior chemotherapy
Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
Absence or irradiated and stable central nervous system metastatic disease
Life expectancy of more than 3 months
Age ≥ 70 years.
Performance status (WHO) < 3
Patients "non-frail" according to comprehensive geriatric assessment
Adequate bone marrow function (Absolute neutrophil count > 1000/mm^3, Platelet count > 100000/mm^3, Hemoglobin > 9gr/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 < 2mg/dl).
Adequate cardiac function (LVEF > 50%).
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 presence of a reliable care giver
Other concurrent investigational agents.