Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

ClinicalTrials.gov ID

NCT00026078

Lead Sponsor

Grupo Oncologico Cooperativo del SurOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

42Estimated

Last Update Posted

Aug 7, 2013Estimated

Start Date

Mar 2001

Official Title

Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer

Brief Summary

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.

Detailed Description

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.

• Breast Cancer

• docetaxel
• ifosfamide

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Lead Sponsor

Grupo Oncologico Cooperativo del SurOTHER

ricrodri@copetel.com.ar54-223-479-3283

medominquez@3net.com.ar0983-33450

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