Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

September 25, 2009 updated by: Hellenic Oncology Research Group

A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Study Type

Interventional

Enrollment (Anticipated)

144

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, Dept. of Medical Oncology
      • Athens, Greece
        • 401 Military Hospital of Athens
      • Athens, Greece
        • Air Forces Military Hospital of Athens
      • Athens, Greece
        • "IASO" General Hospital of Athens, 1st Dept. of Medical Oncology
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
      • Athens, Greece
        • "Marika Iliadis" Hospital of Athens, Dept. of Medical Oncology
      • Larissa, Greece
        • State General Hospital of Larissa, Dept. of Medical Oncology
      • Piraeus, Greece
        • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University Hospital of Crete

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

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 19-75 years.
  • Performance status World Health Organization (WHO) 0-2.
  • Histologically confirmed breast adenocarcinoma.
  • Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or Taxotere + Farmorubicine).
  • Measurable disease.
  • No metastatic central nervous system (CNS) disease.
  • Less than 25% of myeloproductive bone marrow irradiated.
  • Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/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 < 2 mg/dl).
  • Informed consent.

Exclusion Criteria:

  • Pregnancy or nursing.
  • Positive pregnancy test.
  • 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.

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
Active Comparator: 1
Vinorelbine/Gemcitabine (VG)
Drug: Gemcitabine
Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
Other Names:
  • Gemzar
Drug: Vinorelbine
Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles
Other Names:
  • Navelbine
Active Comparator: 2
Capecitabine (Cap)
Drug: Capecitabine
Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to tumor progression between the two treatment arms
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

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, 2002

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 2, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2009

Last Update Submitted That Met QC Criteria

September 25, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/02.11

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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