Breast CancerPhase 2NCT00026078
Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
A Phase 2 study testing docetaxel and ifosfamide in people with Breast Cancer, run by Grupo Oncologico Cooperativo del Sur at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel and ifosfamide
- How many people
- 42 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Mar 2001to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Argentina7 sites, 7 recruiting
- Recruiting
Grupo Oncologico Cooperativo del Sur
Bahía Blanca, Buenos Aires, 8000
Juan Eduardo Perez, MD, 54-291-452-5667, jperez@criba.edu.ar
- Recruiting
Policlinica Privada Instituto De Medicina Nuclear
Bahía Blanca, Buenos Aires, 8000
Alberto Omar Romero, MD, 54-291-453-9848, gocsbhb@bvconline.com.ar
- Recruiting
St. Joseph Medical Center
Manuel B. Gonnet, Buenos Aires, 1987 MB
Sergio Grasso, MD, 54-221-4845088
- Recruiting
C.R I O.
Mar del Plata, 7600
Ricardo L. Rodriguez, MD, 54-223-479-3283, ricrodri@copetel.com.ar
- Recruiting
Unidad Oncologica Del Neuquen
Neuquén, Neuquén Province
Bernardo A. Leone, MD, 54-299-448-5247, bleone@satlink.com
- Recruiting
Sanatorio Santa Rosa S.R.L.
Santa Rosa, La Pampa Province, 6300
Eduardo Heriberto Ortiz, MD, 54-2954-29-715
- Recruiting
Centro Oncologico Tres Arroyos
Tres Arroyos, 7500
Maria Ester Dominguez, MD, 0983-33450, medominquez@3net.com.ar
Mexico1 site, 1 recruiting
- Recruiting
Centro Medico Nacional de Occidente
Guadalajara, Jalisco, 4430
Gilberto Morgan Villela, MD, 523-641-5081
About this study
Official title: Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, ifosfamide
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
ifosfamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Oncologico Cooperativo del Sur
- Sponsor type
- University, hospital or other
- Investigators
- Bernardo A. Leone, MD, Study chair, Unidad Oncologica Del Neuquen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026078
- Sponsor's protocol ID
- GOCS-02-BR-01
- Other IDs
- CDR0000068969, NCI-V01-1670
- Status last verified
- Nov 2006
- First submitted
- 9 Nov 2001
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00026078
- Acronym / sponsor ID
- GOCS-02-BR-01
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Grupo Oncologico Cooperativo del SurUniversity, hospital or other
- Study start
- Mar 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| ifosfamide | Drug | – |
Primary outcome
Response rate
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Policlinica Privada Instituto De Medicina Nuclear
Bahía Blanca, Argentina
Bernardo A. Leone, MD study chair
Unidad Oncologica Del Neuquen
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and ifosfamide in people with Breast Cancer, run by Grupo Oncologico Cooperativo del Sur at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.