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

Non-small-cell Lung Cancer Clinical Trial

Official title:

A Multicenter Randomized Phase III Study of the Docetaxel and Gemcitabine Combination Versus Monotherapy With Gemcitabine as First-line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00442026
• Other study ID #: CT/06.11
• Status: Terminated
• Phase: Phase 3
• First received: February 28, 2007
• Last updated: June 26, 2012
• Start date: December 2006
• Est. completion date: May 2010

Study information

• Verified date: June 2012
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small-cell Lung Cancer

Intervention

Drug:
• Docetaxel
Docetaxel at the dose of 30mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
• Gemcitabine
Gemcitabine at the dose of 900mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles
• Gemcitabine
Gemcitabine at the dose of 1200mg/m2 IV on days 1 and 8 every 3 weeks for 6 consecutive cycles

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	401 Military Hospital, Medical Oncology Unit	Athens
Greece	Air Forces Military Hospital, Dep of Medical Oncology	Athens
Greece	IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases	Athens
Greece	Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases	Athens
Greece	"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology	Piraeus
Greece	Theagenion" Anticancer Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival between the two treatment arms		Probability of 1 year survival (%)	No
Secondary	Overall response rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Time to disease progression		1 year	No
Secondary	Quality of life assessment		Assessment every two cycles	No
Secondary	Toxicity profile		Assessment every two cycles	Yes