Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

August 6, 2013 updated by: Grupo Oncologico Cooperativo del Sur

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.

Study Overview

Status

Unknown

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Mar del Plata, Argentina, 7600
    - Recruiting
    - C.R I O.
    - Contact:
      
      Ricardo L. Rodriguez, MD
      
      Phone Number: 54-223-479-3283
      
      Email: ricrodri@copetel.com.ar
  - Neuquen, Argentina
    - Recruiting
    - Unidad Oncologica del Neuquen
    - Contact:
      
      Bernardo A. Leone, MD
      
      Phone Number: 54-299-448-5247
      
      Email: bleone@satlink.com
  - Tres Arroyos, Argentina, 7500
    - Recruiting
    - Centro Oncologico Tres Arroyos
    - Contact:
      
      Maria Ester Dominguez, MD
      
      Phone Number: 0983-33450
      
      Email: medominquez@3net.com.ar
- Buenos Aires
  - Bahia Blanca, Buenos Aires, Argentina, 8000
    - Recruiting
    - Grupo Oncologico Cooperativo del Sur
    - Contact:
      
      Juan Eduardo Perez, MD
      
      Phone Number: 54-291-452-5667
      
      Email: jperez@criba.edu.ar
  - Bahia Blanca, Buenos Aires, Argentina, 8000
    - Recruiting
    - Policlínica Privada Instituto de Medicina Nuclear
    - Contact:
      
      Alberto Omar Romero, MD
      
      Phone Number: 54-291-453-9848
      
      Email: gocsbhb@bvconline.com.ar
  - Gonnet, Buenos Aires, Argentina, 1987 MB
    - Recruiting
    - St. Joseph Medical Center
    - Contact:
      
      Sergio Grasso, MD
      
      Phone Number: 54-221-4845088
- La Pampa
  - Santa Rosa, La Pampa, Argentina, 6300
    - Recruiting
    - Sanatorio Santa Rosa S.R.L.
    - Contact:
      
      Eduardo Heriberto Ortiz, MD
      
      Phone Number: 54-2954-29-715
Mexico
- Jalisco
  - Guadalajara, Jalisco, Mexico, 4430
    - Recruiting
    - Centro Médico Nacional de Occidente
    - Contact:
      
      Gilberto Morgan Villela, MD
      
      Phone Number: 523-641-5081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Time to treatment failure
Duration of response
Survival
Toxicity as assessed by CTC version 2.0
Quality of life as assessed by Schipper's Functional Living Index - Cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Oncologico Cooperativo del Sur

Investigators

Study Chair: Bernardo A. Leone, MD, Unidad Oncologica del Neuquen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Registration Dates

First Submitted

November 9, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

GOCS-02-BR-01
CDR0000068969 (Registry Identifier: PDQ (Physician Data Query))
NCI-V01-1670

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.