Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: Phase II Study:

  • Compare the response rate in women with previously treated metastatic breast cancer treated with capecitabine vs vinorelbine.
  • Compare the duration of response in patients treated with these drugs.

Phase III Study:

  • Compare overall and progression-free survival in patients treated with these drugs.
  • Compare time to treatment failure in patients treated with these drugs.
  • Compare overall safety of these drugs in these patients.
  • Compare quality of life and clinical benefit response in patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and taxane resistance (refractory vs resistant vs sensitive).

  • Phase II: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive vinorelbine IV on days 1 and 8. Courses repeat every 21 days.
    • Arm II: Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days.

In both arms, treatment continues in the absence of progression or unacceptable toxicity.

If sufficient response rate is determined in phase II, the phase III study is initiated.

  • Phase III: Patients are randomized and receive treatment as in phase II. Quality of life is assessed prior to randomization, at weeks 3, 6, 9, 18, 24, and 30, and then every 12 weeks until disease progression.

Clinical benefit response is assessed daily while patient is on study.

Patients are followed every 6 weeks until disease progression and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for phase II of this study and a total of 406-452 patients (203-226 per treatment arm) will be accrued for phase III of this study within 18.5 months.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • 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

  • Belgium
      • Antwerp, Belgium, 2020
        • Ziekenhuis Network Antwerpen Middelheim
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Wilrijk, Belgium, 2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Germany
      • Nurberg, Germany, 90471
        • Klinikum Nuernberg - Klinikum Sued
  • Slovenia
      • Ljubljana, Slovenia, Sl-1000
        • Institute of Oncology - Ljubljana
  • United Kingdom
    • England
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Beatson Oncology Centre

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • Metastatic disease

  • Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting

    • Taxane-resistant disease allowed regardless of duration of prior therapy NOTE: Resistant disease defined as progression during or within 12 weeks after taxane therapy for metastatic disease or a disease-free interval of less than 12 months after neoadjuvant or adjuvant therapy with a taxane
    • Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE: Sensitive disease defined as progression occurring more than 12 weeks after taxane therapy for metastatic disease or more than 12 months after neoadjuvant or adjuvant therapy with a taxane
  • Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR medical contraindication to treatment with anthracyclines
  • At least one unidimensionally measurable lesion (phase II study)
  • No CNS metastases

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

  • Creatinine clearance greater than 50 mL/min

Cardiovascular

  • No symptomatic ventricular arrhythmias
  • No clinically significant congestive heart failure
  • No clinical or ECG evidence of myocardial infarction within the past 12 months
  • No significant coronary artery disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior malignancy within the past 5 years except contralateral breast cancer, nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix
  • No known or prior sensitivity to fluoropyrimidines, including fluorouracil
  • No pre-existing grade 2 or greater neurotoxicity
  • No known malabsorption or upper gastrointestinal abnormalities that would affect absorption of study drug
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy

Chemotherapy

  • See Disease Characteristics
  • No more than 2 prior chemotherapy lines for metastatic disease
  • No prior capecitabine, vinca alkaloids, or continuous fluorouracil
  • No other concurrent chemotherapy

Endocrine therapy

  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • Bisphosphonate therapy for treatment and prevention of bony metastases allowed if initiated prior to study
  • No other concurrent investigational treatment
  • No concurrent brivudine with capecitabine

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

Collaborators and Investigators

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Chris Twelves, MD, BMedSci, FRCP, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2002

Primary Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-10001-160010
  • EORTC-10001
  • EORTC-16001O
  • IDBBC-EORTC-10001

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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