Breast CancerPhase 2NCT00010075
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
A Phase 2 study testing fluorouracil, leucovorin calcium and mitoxantrone hydrochloride in people with Breast Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 75 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- fluorouracil, leucovorin calcium and mitoxantrone hydrochloride
- How many people
- Not given
- Where
- 6 sitesFrance
- Study dates
- Jan 2000to 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 75 to 90 years
- Women only
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic adenocarcinoma of the breast
- Bidimensionally measurable or evaluable disease
- At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR
- Serous drainage, cutaneous metastasis, osseous metastasis, etc.
- No symptomatic cerebral metastasis
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 75 to 90
Sex:
- Female
Menopausal status:
- Postmenopausal
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
Hepatic:
- Alkaline phosphatase less than 3 times normal
- Bilirubin less than 1.5 times normal
- Transaminases less than 3 times normal
- Total protein greater than 60%
- Albumin greater than 30 g/L
Renal:
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- LVEF greater than 50% by echocardiogram or scintigraph
- ECG normal
- No uncontrolled angina
- No myocardial infarction within past 6 months
Other:
- No other medical illness or condition that would preclude study
- No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
- No psychological, social, familial, or geographical reasons that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior adjuvant chemotherapy allowed
- No prior adjuvant anthracyclines
- No prior chemotherapy for metastatic disease
Endocrine therapy:
- One or two prior regimens of hormonal therapy allowed for metastatic disease
Radiotherapy:
- No prior radiotherapy for metastatic disease
Surgery:
- Not specified
Other:
- No concurrent participation in another study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier Victor Dupouy
Argenteuil, 95107
Polyclinique De Courlancy
Metz, 55038
Hopital Saint Antoine
Paris, 75571
Hopital Tenon
Paris, 75970
C.H. Senlis
Senlis, 60309
Centre Medico-Chirurgical Foch
Suresnes, 92151
About this study
Official title: Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone.
- Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients.
- Determine the tolerance of these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after 3 courses, and at treatment completion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- fluorouracil, leucovorin calcium, mitoxantrone hydrochloride
- 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.
fluorouracilDrug
mitoxantrone hydrochlorideDrug
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 startJan 2000
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
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Elisabeth Carola, MD, Study chair, C.H. Senlis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010075
- Sponsor's protocol ID
- CDR0000068439
- Other IDs
- FRE-GERCOR-SAM-S99-1, EU-20028
- Status last verified
- Jun 2003
- First submitted
- 2 Feb 2001
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
- ClinicalTrials.gov ID
- NCT00010075
- Acronym / sponsor ID
- CDR0000068439
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Jan 2000
- 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. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone.
- Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients.
- Determine the tolerance of these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after 3 courses, and at treatment completion.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 75 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| mitoxantrone hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
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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.
Elisabeth Carola, MD study chair
C.H. Senlis
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorouracil, leucovorin calcium and mitoxantrone hydrochloride in people with Breast Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 6 sites in France.
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 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 24 Jul 2008.