Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	21 to 75	Other	GOCS-02-BR-01 NCI-V01-1670, NCT00026078

Objectives

1. Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer.
2. Determine the response rate and duration of response of patients treated with this regimen.
3. Determine the time to treatment failure and survival of patients treated with this regimen.
4. Determine the toxicity of this regimen in these patients.
5. Determine the quality of life of patients treated with this regimen.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 15-42 patients will be accrued for this study.

Outcomes

Response rate

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

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.

Trial Contact Information

Trial Lead Organizations

Grupo Oncologico Cooperativo del Sur

Bernardo A. Leone, MD, Protocol chair		Ph: 54-299-448-5247 Email: bleone@satlink.com

Argentina
	Mar del Plata
	C.R I O.
		Ricardo Rodriguez, MD	Ph:  54-223-479-3283
			Email: ricrodri@copetel.com.ar
	Tres Arroyos
	Centro Oncologico Tres Arroyos
		Maria Ester Dominguez, MD	Ph:  0983-33450
			Email: medominquez@3net.com.ar
Buenos Aires
	Bahia Blanca
	Grupo Oncologico Cooperativo del Sur
		Juan Eduardo Perez, MD	Ph:  54-291-452-5667
			Email: jperez@criba.edu.ar
	Policlinica Privada Instituto De Medicina Nuclear
		Alberto Omar Romero, MD	Ph:  54-291-453-9848
			Email: gocsbhb@bvconline.com.ar
		Mario Raul Machiavelli, MD	Ph:  54-91-39-848
	Gonnet
	St. Joseph Medical Center
		Sergio Grasso, MD	Ph:  54-221-4845088
La Pampa
	Santa Rosa
	Sanatorio Santa Rosa S.R.L.
		Eduardo Heriberto Ortiz, MD	Ph:  54-2954-29-715
Neuquen
	Neuquen
	Unidad Oncologica Del Neuquen
		Bernardo A. Leone, MD	Ph:  54-299-448-5247
			Email: bleone@satlink.com
Mexico
Jalisco
	Guadalajara
	Centro Medico Nacional de Occidente
		Gilberto Morgan Villela, MD	Ph:  523-641-5081

Registry Information
Official Title		Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
Trial Start Date		2001-03-15
Registered in ClinicalTrials.gov		NCT00026078
Date Submitted to PDQ		2001-08-10
Information Last Verified		2006-11-28

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