Clinical trial NCT00026078: Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
Official title: Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 42
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Response rate
Secondary outcomes:
measure: Time to treatment failure
measure: Duration of response
measure: Survival
measure: Toxicity as assessed by CTC version 2.0
measure: Quality of life as assessed by Schipper's Functional Living Index - Cancer
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Grupo Oncologico Cooperativo del Sur
state: Buenos Aires
city: Bahia Blanca
country: Argentina
facility: Policlinica Privada Instituto De Medicina Nuclear
state: Buenos Aires
city: Gonnet
country: Argentina
facility: St. Joseph Medical Center
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Sanatorio Santa Rosa S.R.L.
state: La Pampa
city: Mar del Plata
country: Argentina
facility: C.R I O.
city: Neuquen
country: Argentina
facility: Unidad Oncologica Del Neuquen
city: Tres Arroyos
country: Argentina
facility: Centro Oncologico Tres Arroyos
city: Guadalajara
country: Mexico
facility: Centro Medico Nacional de Occidente
state: Jalisco
Study officials:
affiliation: Unidad Oncologica Del Neuquen
name: Bernardo A. Leone, MD
role: STUDY_CHAIR
References: