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Trial record 12 of 13 for:    "National Cancer Institute (NCI)" [Exact] | ( Map: Mexico )

Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00026078
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 9, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE March 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2006)
Response rate
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00026078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
Official Title  ICMJE Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: docetaxel
  • Drug: ifosfamide
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
42
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00026078
Other Study ID Numbers  ICMJE GOCS-02-BR-01
CDR0000068969 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-V01-1670
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Grupo Oncologico Cooperativo del Sur
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bernardo A. Leone, MD Unidad Oncologica Del Neuquen
PRS Account National Cancer Institute (NCI)
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP