Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031876
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine Drug: paclitaxel Phase 1 Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer
Study Start Date : May 2000
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 64


  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 12 weeks


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


  • 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)


  • 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


  • No grade 2 or greater atrioventricular block


  • 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


Biologic therapy:

  • Not specified


  • 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


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


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031876

Inselspital, Bern
Bern, Switzerland, CH-3010
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Stefan Aebi, MD University Hospital Inselspital, Berne

Publications of Results:
Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00031876     History of Changes
Other Study ID Numbers: SAKK 26/00
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Swiss Group for Clinical Cancer Research:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic