Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00026078
• Other study ID #: GOCS-02-BR-01
• Secondary ID: CDR0000068969NCI
• Status: Recruiting
• Phase: Phase 2
• First received: November 9, 2001
• Last updated: August 6, 2013
• Start date: March 2001

Study information

• Verified date: November 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

• ifosfamide

Locations

Country	Name	City	State
Argentina	Grupo Oncologico Cooperativo del Sur	Bahia Blanca	Buenos Aires
Argentina	Policlinica Privada Instituto De Medicina Nuclear	Bahia Blanca	Buenos Aires
Argentina	St. Joseph Medical Center	Gonnet	Buenos Aires
Argentina	C.R I O.	Mar del Plata
Argentina	Unidad Oncologica Del Neuquen	Neuquen
Argentina	Sanatorio Santa Rosa S.R.L.	Santa Rosa	La Pampa
Argentina	Centro Oncologico Tres Arroyos	Tres Arroyos
Mexico	Centro Medico Nacional de Occidente	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Oncologico Cooperativo del Sur

Countries where clinical trial is conducted

Argentina,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	Time to treatment failure			No
Secondary	Duration of response			No
Secondary	Survival			No
Secondary	Toxicity as assessed by CTC version 2.0			Yes
Secondary	Quality of life as assessed by Schipper's Functional Living Index - Cancer			No