Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

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: Breast Cancer
• Intervention / Treatment: Drug: Gemcitabine; Drug: Vinorelbine; Drug: Capecitabine

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	1 year

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group
• Collaborators: University Hospital of Crete

Study record dates

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: Gemcitabine; Capecitabine; Breast cancer; Chemotherapy; Vinorelbine
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Capecitabine; Vinorelbine
• Other Study ID Numbers: CT/02.11