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

October 29, 2008 updated by: Hellenic Oncology Research Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • "Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
      • 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
        • " General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
VG
Drug: Vinorelbine
Vinorelbine (oral) 70 mg/m2, on days 1 and 15 every 4 weeks for 6 cycles
Other Names:
  • Navelbine
Drug: Gemcitabine
Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Other Names:
  • Gemzar
Drug: Gemcitabine
Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
Other Names:
  • Gemzar
Experimental: 2
DG
Drug: Gemcitabine
Gemcitabine 900 mg/m2 on days 1 and 15 every 4 weeks for 6 cycles
Other Names:
  • Gemzar
Drug: Gemcitabine
Gemcitabine 1000 mg/m2 intravenous, on days 1 and 8 every 3 weeks for 6 cycles
Other Names:
  • Gemzar
Drug: Docetaxel
Docetaxel 75 mg/m2 intravenous on day 8 every 3 weeks for 6 cycles
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to tumor progression
Time Frame: 1 year
1 year
Toxicity
Time Frame: Toxicity assessment on each chemotherapy cycle
Toxicity assessment on each chemotherapy cycle
Quality of life
Time Frame: Assessment every two cycles
Assessment every two cycles
Response rate
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 29, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/04.04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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