Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026078
First received: November 9, 2001
Last updated: August 6, 2013
Last verified: November 2006
  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 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Argentina
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   
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   
St. Joseph Medical Center Recruiting
Gonnet, Buenos Aires, Argentina, 1987 MB
Contact: Sergio Grasso, MD    54-221-4845088      
Sanatorio Santa Rosa S.R.L. Recruiting
Santa Rosa, La Pampa, Argentina, 6300
Contact: Eduardo Heriberto Ortiz, MD    54-2954-29-715      
C.R I O. Recruiting
Mar del Plata, Argentina, 7600
Contact: Ricardo L. Rodriguez, MD    54-223-479-3283    ricrodri@copetel.com.ar   
Unidad Oncologica Del Neuquen Recruiting
Neuquen, Argentina
Contact: Bernardo A. Leone, MD    54-299-448-5247    bleone@satlink.com   
Centro Oncologico Tres Arroyos Recruiting
Tres Arroyos, Argentina, 7500
Contact: Maria Ester Dominguez, MD    0983-33450    medominquez@3net.com.ar   
Mexico
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00026078     History of Changes
Other Study ID Numbers: GOCS-02-BR-01, CDR0000068969, NCI-V01-1670
Study First Received: November 9, 2001
Last Updated: August 6, 2013
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Ifosfamide
Isophosphamide mustard
Docetaxel
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014