Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

NCT00441740 | Completed Phase 3

• 1 other identifier: CT/04.04
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to evaluate whether the gemcitabine/vinorelbine combination versus the gemcitabine/docetaxel combination as first line treatment, offers a survival advantage in patients with locally advanced/metastatic NSCLC.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; 1st line treatment; Gemcitabine; Vinorelbine; Docetaxel

Outcome Measures

Primary Outcomes (1)

• Overall survival

  1 year

Secondary Outcomes (4)

• Response rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

• Time to tumor progression

  1 year

• Toxicity

  Toxicity assessment on each chemotherapy cycle

• Quality of life

  Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

VG

Drug: Vinorelbine; Drug: Gemcitabine

2

EXPERIMENTAL

DG

Drug: Docetaxel; Drug: Gemcitabine

Interventions

Vinorelbine DRUG

Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles

Also known as: Navelbine

1

Gemcitabine DRUG

Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles

Also known as: Gemzar

1

Docetaxel DRUG

Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles

Also known as: Taxotere

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
• No previous therapy for advanced/metastatic NSCLC is allowed
• Age \> 18 years
• Bidimensionally measurable disease
• Performance status (WHO) 0-2
• Adequate liver (serum bilirubin \< 1.5 times the upper normal limit (UNL); AST and ALT \< 2.5 times the UNL in the absence of demonstrable liver metastases, or \< 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \< 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
• Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
• Life expectancy of more than 3 months
• Patient able to take oral medication
• At least 4 weeks since prior radiotherapy
• Written informed consent

You may not qualify if:

• Active infection
• History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• Malnutrition (loss of ≥ 20% of the original body weight)
• Performance status: 3-4
• Sensor or motor neuropathy \> grade I
• Second primary malignancy, except for non-melanoma skin cancer
• Psychiatric illness or social situation that would preclude study compliance
• Pregnant or lactating women
• Known, symptomatic central nervous system metastases

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

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

Athens, Greece

Location

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

Athens, Greece

Location

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

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

"Theagenion" Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine; Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Vassilis Georgoulias, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: April 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: October 31, 2008

Record last verified: 2008-10

Locations

GR (9)