Breast CancerPhase 2NCT00002498
Combination Chemotherapy Compared With Mitoxantrone in Treating Older Patients With Advanced Breast Cancer
A Phase 2 study testing CMF regimen, cyclophosphamide and fluorouracil in people with Breast Cancer, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different combinations may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CMF regimen, cyclophosphamide and fluorouracil
- How many people
- Not given
- Where
- 2 sitesNetherlands
- Study dates
- Jul 1992to 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS: Histologically proven, progressive, recurrent or metastatic breast cancer in patients over 70 years of age Measurable or evaluable disease required, including: Lesions of the mediastinum, retroperitoneum, or liver at least 3 cm in diameter on CT scan or ultrasound The following are not considered measurable or evaluable: Lymphedema Hilar enlargement Pleural effusion Ascites Bone marrow infiltration Osteoblastic skeletal lesion No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Over 70 Sex: Not specified Menopausal status: Postmenopausal Performance status: WHO 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin less than 1.4 mg/dL (25 micromoles/L) Renal: Creatinine clearance (calculated) greater than 50 mL/min in patients weighing at least 45 kg and measured creatinine clearance at least 50 mL/min in patients weighing less than 45 kg Cardiovascular: No congestive heart failure No myocardial infarction within 6 months No severe arrhythmia No complete bundle branch block Other: No active uncontrolled infection No mental disorders that may preclude patient follow-up No second malignancy except: Adequately treated basal cell carcinoma of the skin Adequately treated in situ carcinoma of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced disease At least 1 year since prior adjuvant chemotherapy Endocrine therapy: At least 4 weeks since prior estrogens, androgens, and progestins Tamoxifen or aminoglutethimide allowed with no waiting period if disease progresses Recovery from prior hormonal therapy for metastatic disease required Radiotherapy: Prior radiotherapy allowed provided: Evaluable disease exists outside of treatment field No greater than 50% of bone marrow was irradiated Surgery: Not specified
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Leiden University Medical Center
Leiden, 2300 ZA
St. Radboud University Hospital
Nijmegen, 6500 HB
About this study
Official title: CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different combinations may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide, methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent or metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the response rate and duration of response of elderly patients with advanced breast cancer treated with first-line chemotherapy with mitigated "classical" CMF (cyclophosphamide/methotrexate/fluorouracil) vs. mitoxantrone (DHAD). II. Define the morbidity of CMF and DHAD in elderly patients. III. Determine quality of life in these patients.
OUTLINE: This is a randomized study. Patients are stratified by participating institution. The first group receives oral cyclophosphamide on days 1 through 14 and intravenous methotrexate and fluorouracil on days 1 and 8. Courses repeat every 4 weeks for a maximum of 6 courses. The second group receives intravenous mitoxantrone every 3 weeks for a maximum of 8 courses. Concomitant therapy with hepatotoxic or nephrotoxic drugs (e.g., NSAIDs) or corticosteroids (even as antiemetics) is not permitted in either group. Radiotherapy is allowed provided no more than 50% of the bone marrow is irradiated and at least 1 indicator lesion is unirradiated. Patients who complete therapy are followed every 3 months until disease progression.
PROJECTED ACCRUAL: 60 patients will be accrued over approximately 1 year. If extreme differences between arms exist after entry of 30 patients, accrual may be stopped early.
- Conditions
- Breast Cancer
- Being tested
- CMF regimen, cyclophosphamide, fluorouracil, methotrexate, 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.
CMF regimenDrug
cyclophosphamideDrug
fluorouracilDrug
methotrexateDrug
mitoxantrone hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2004 (estimated)
- Study startJul 1992
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.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Marianne A. Nooij, MD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002498
- Sponsor's protocol ID
- CDR0000077804
- Other IDs
- DUT-KWF-CKVO-9008, EU-92006
- Status last verified
- May 2000
- First submitted
- 1 Nov 1999
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY
- ClinicalTrials.gov ID
- NCT00002498
- Acronym / sponsor ID
- CDR0000077804
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Jul 1992
- First posted
- 23 Aug 2004 (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. Giving drugs in different combinations may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide, methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent or metastatic breast cancer.
Detailed description
OBJECTIVES: I. Determine the response rate and duration of response of elderly patients with advanced breast cancer treated with first-line chemotherapy with mitigated "classical" CMF (cyclophosphamide/methotrexate/fluorouracil) vs. mitoxantrone (DHAD). II. Define the morbidity of CMF and DHAD in elderly patients. III. Determine quality of life in these patients.
OUTLINE: This is a randomized study. Patients are stratified by participating institution. The first group receives oral cyclophosphamide on days 1 through 14 and intravenous methotrexate and fluorouracil on days 1 and 8. Courses repeat every 4 weeks for a maximum of 6 courses. The second group receives intravenous mitoxantrone every 3 weeks for a maximum of 8 courses. Concomitant therapy with hepatotoxic or nephrotoxic drugs (e.g., NSAIDs) or corticosteroids (even as antiemetics) is not permitted in either group. Radiotherapy is allowed provided no more than 50% of the bone marrow is irradiated and at least 1 indicator lesion is unirradiated. Patients who complete therapy are followed every 3 months until disease progression.
PROJECTED ACCRUAL: 60 patients will be accrued over approximately 1 year. If extreme differences between arms exist after entry of 30 patients, accrual may be stopped early.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- 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 |
|---|---|---|
| CMF regimen | Drug | – |
| cyclophosphamide | Drug | – |
| fluorouracil | Drug | – |
| methotrexate | 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 18 Dec 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.
Marianne A. Nooij, MD study chair
Leiden University Medical Center
2 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 CMF regimen, cyclophosphamide and fluorouracil in people with Breast Cancer, run by Leiden University Medical Center at 2 sites in Netherlands.
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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 18 Dec 2013.