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Clinical Trials/NCT00442026
NCT00442026TerminatedPhase 3

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)

Hellenic Oncology Research Group9 sites in 1 country106 target enrollmentStarted: December 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Sponsor
Enrollment
106
Locations
9
Primary Endpoint
Overall survival between the two treatment arms
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
70 Years to 85 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

1

Experimental

DG

Intervention: Docetaxel (Drug)

1

Experimental

DG

Intervention: Gemcitabine (Drug)

2

Experimental

G

Intervention: Gemcitabine (Drug)

Outcomes

Primary Outcomes

Overall survival between the two treatment arms

Time Frame: Probability of 1 year survival (%)

Secondary Outcomes

  • 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)

Investigators

Sponsor
Hellenic Oncology Research Group
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (9)

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