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Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2006

Sponsored by: Grupo Oncologico Cooperativo del Sur
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026078
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: ifosfamide
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

Drug Information available for:   Ifosfamide    Docetaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC version 2.0 [ Designated as safety issue: Yes ]
  • Quality of life as assessed by Schipper's Functional Living Index - Cancer [ Designated as safety issue: No ]

Estimated Enrollment:   42
Study Start Date:   March 2001

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
Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026078

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

Sponsors and Collaborators
Grupo Oncologico Cooperativo del Sur

Investigators
Study Chair:     Bernardo A. Leone, MD     Unidad Oncologica Del Neuquen    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068969, GOCS-02-BR-01, NCI-V01-1670
First Received:   November 9, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00026078
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
recurrent breast cancer  

Study placed in the following topic categories:
Docetaxel
Ifosfamide
Skin Diseases
Mechlorethamine
Breast Neoplasms
Breast Diseases
Recurrence
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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