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

Phase 3

Terminated

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: Docetaxel; Drug: Gemcitabine

• Registration Number: NCT00442026
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	DG
1	Gemcitabine	DG
2	Gemcitabine	G

Primary Outcome Measures

Name	Time	Method
Overall survival between the two treatment arms	Probability of 1 year survival (%)

Secondary Outcome Measures

Name	Time	Method
Overall response rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Time to disease progression	1 year
Quality of life assessment	Assessment every two cycles
Toxicity profile	Assessment every two cycles

Trial Locations

Locations (9)

IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

Air Forces Military Hospital, Dep of Medical Oncology; 🇬🇷 Athens, Greece

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases; 🇬🇷 Athens, Greece

401 Military Hospital, Medical Oncology Unit; 🇬🇷 Athens, Greece

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases; 🇬🇷 Athens, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

Theagenion" Anticancer Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece