Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026078
First received: November 9, 2001
Last updated: August 6, 2013
Last verified: November 2006

November 9, 2001
August 6, 2013
March 2001
Not Provided
Response rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00026078 on ClinicalTrials.gov Archive Site
  • Time to treatment failure [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC version 2.0 [ Designated as safety issue: Yes ]
  • Quality of life as assessed by Schipper's Functional Living Index - Cancer [ Designated as safety issue: No ]
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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.

OBJECTIVES:

  • 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.

Interventional
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.
 
Recruiting
42
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 21 to 75

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • More than 12 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent drinks containing caffeine or alcohol
Female
21 Years to 75 Years
No
Argentina,   Mexico
 
NCT00026078
GOCS-02-BR-01, CDR0000068969, NCI-V01-1670
Not Provided
Not Provided
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