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


Phase 2
21 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Bernardo A. Leone, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Unidad Oncologica Del Neuquen

Authority:

Unspecified

Study ID:

CDR0000068969

NCT ID:

NCT00026078

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

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