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Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00026078
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

November 9, 2001
January 27, 2003
August 7, 2013
March 2001
Not Provided
Response rate
Not Provided
Complete list of historical versions of study NCT00026078 on ClinicalTrials.gov Archive Site
  • Time to treatment failure
  • Duration of response
  • Survival
  • Toxicity as assessed by CTC version 2.0
  • Quality of life as assessed by Schipper's Functional Living Index - Cancer
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Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer.


  • Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer.
  • Determine the response rate and duration of response of patients treated with this regimen.
  • Determine the time to treatment failure and survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour (beginning 1 hour after docetaxel infusion) on days 1-3. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every month during study, and then every 3 months after completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 15-42 patients will be accrued for this study.

Phase 2
Primary Purpose: Treatment
Breast Cancer
  • Drug: docetaxel
  • Drug: ifosfamide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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  • Histologically confirmed metastatic breast cancer
  • Bidimensionally measurable lesions

    • The following are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
  • Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation
  • No CNS metastases
  • Hormone receptor status:

    • Not specified



  • 21 to 75


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • More than 12 weeks


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 11 g/dL


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • SGOT no greater than 1.25 times ULN


  • Creatinine clearance at least 60 mL/min


  • No history of congestive heart failure
  • No myocardial infarction within the past 6 months
  • No active ischemic heart disease
  • No uncontrolled hypertension


  • Not pregnant
  • No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other medical or psychiatric diseases that would preclude study
  • No geographical situation that would preclude study
  • No history of alcohol abuse


Biologic therapy:

  • Not specified


  • No prior adjuvant chemotherapy including ifosfamide or docetaxel
  • No prior systemic chemotherapy for metastatic breast cancer

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent corticoids, gestagens, or androgens unless strictly indicated


  • Not specified


  • Not specified


  • No concurrent drinks containing caffeine or alcohol
Sexes Eligible for Study: Female
21 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Mexico
CDR0000068969 ( Registry Identifier: PDQ (Physician Data Query) )
Not Provided
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Grupo Oncologico Cooperativo del Sur
Not Provided
Study Chair: Bernardo A. Leone, MD Unidad Oncologica Del Neuquen
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP