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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Vinorelbine
Gemcitabine
Docetaxel
Gemcitabine
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, 1st line treatment, Gemcitabine, Vinorelbine, Docetaxel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

VG

DG

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Response rate
Time to tumor progression
Toxicity
Quality of life

Full Information

First Posted
February 28, 2007
Last Updated
October 29, 2008
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00441740
Brief Title
Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer
Official Title
Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC. However, several trials comparing platinum versus non-platinum based chemotherapy regimens failed to demonstrate a statistically significant difference in terms of time to tumor progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of these two doublets, would be interesting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
NSCLC, 1st line treatment, Gemcitabine, Vinorelbine, Docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
VG
Arm Title
2
Arm Type
Experimental
Arm Description
DG
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Description
Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Title
Time to tumor progression
Time Frame
1 year
Title
Toxicity
Time Frame
Toxicity assessment on each chemotherapy cycle
Title
Quality of life
Time Frame
Assessment every two cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vassilis Georgoulias, MD
Organizational Affiliation
University Hospital of Crete, Dep of Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
401 Military Hospital, Medical Oncology Unit
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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