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

NCT00442026 | Terminated Phase 3

• 1 other identifier: CT/06.11
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 9

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

Conditions

Non-small-cell Lung Cancer

Keywords

Cancer; NSCLC; Elderly; Chemotherapy; Docetaxel; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Overall survival between the two treatment arms

  Probability of 1 year survival (%)

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

DG

Drug: Docetaxel; Drug: Gemcitabine

2

EXPERIMENTAL

G

Drug: Gemcitabine

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

1

Gemcitabine DRUG

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

Also known as: Gemzar

1

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (9)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases

Athens, Greece

Location

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

Piraeus, Greece

Location

Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

Related Publications (1)

• Karampeazis A, Vamvakas L, Kotsakis A, Christophyllakis C, Kentepozidis N, Chandrinos V, Agelidou A, Polyzos A, Tsiafaki X, Hatzidaki D, Georgoulias V. Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment: Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study. J Geriatr Oncol. 2017 Jan;8(1):23-30. doi: 10.1016/j.jgo.2016.05.002. Epub 2016 Jun 2.

  PMID: 27264267 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lampros Vamvakas, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

• Athanasios Karampeazis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: December 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

GR (9)