Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
Recruitment status was Recruiting
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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 |
- Response rate [ Designated as safety issue: No ]
- 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 |
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 |
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| 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 | |
| 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: | CDR0000068969, GOCS-02-BR-01, NCI-V01-1670 |
| Study First Received: | November 9, 2001 |
| Last Updated: | February 19, 2009 |
| 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 June 17, 2013