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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Non-small-cell Lung Cancer

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

DG

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Gemcitabine

Intervention Type DRUG

Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

2

G

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine at the dose of 1200mg/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 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Intervention Type DRUG

Gemcitabine

Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Intervention Type DRUG

Gemcitabine

Gemcitabine at the dose of 1200mg/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 Gemzar Gemzar

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No