Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

May 14, 2012 updated by: Swiss Group for Clinical Cancer Research

Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of capecitabine when combined with paclitaxel in patients with metastatic adenocarcinoma of the breast.
  • Determine the clinical efficacy of the dose immediately preceding the MTD identified in phase I, in terms of response rate, time to treatment failure, time to disease progression, and overall survival, in these patients.
  • Determine the toxicity of this regimen in these patients.
  • Determine a well-tolerated drug combination for these patients.

OUTLINE: This is a dose-escalation, multicenter study of capecitabine.

Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the dose level immediately preceding the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and 15-46 patients will be accrued for phase II of this study.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

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

  • Switzerland
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Zurich, Switzerland, CH-8091
        • UniversitaetsSpital

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic adenocarcinoma of the breast

  • Patients in phase I:

    • Evaluable disease

  • Patients in phase II:

    • Bidimensionally measurable disease

      • Bone metastases are not considered measurable
  • No known or clinically suspected CNS metastases

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 to 64

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC greater than 3,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2 times ULN (3 times ULN if liver metastases present)

Renal:

  • Patients in phase I:

    • Creatinine clearance at least 50 mL/min

  • Patients in phase I or II:

    • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No grade 2 or greater atrioventricular block

Other:

  • No cognitive impairment or severe psychiatric disorder
  • No greater than grade 2 preexisting peripheral neuropathy
  • No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • Able to tolerate steroid premedication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • More than 6 months since prior adjuvant chemotherapy
  • At least 1 year since prior continuous infusion of fluorouracil or capecitabine
  • At least 1 year since prior taxane administered once every 3 weeks
  • No prior taxane or capecitabine administered weekly
  • No more than 1 prior chemotherapy regimen for metastatic or locally advanced breast cancer
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior hormonal treatment for metastatic breast cancer allowed
  • No concurrent continuous glucocorticosteroids
  • No concurrent systemic endocrine treatment for breast cancer

Radiotherapy:

  • No concurrent radiotherapy to indicator lesion or more than 30% of bone marrow

Surgery:

  • Not specified

Other:

  • No other concurrent anticancer treatment
  • No concurrent immunosuppressive drugs
  • Concurrent bisphosphonates allowed if indicator lesion is non-bone
  • Able to tolerate steroid premedication

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Stefan Aebi, MD, University Hospital Inselspital, Berne

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

May 1, 2000

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 26/00
  • EU-20135

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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