Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00031876
First received: March 8, 2002
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Enrollment: 34
Study Start Date: May 2000
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031876

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

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00031876     History of Changes
Other Study ID Numbers: SAKK 26/00, EU-20135
Study First Received: March 8, 2002
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

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
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on September 30, 2014