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Breast CancerPhase 1NCT00002866

Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer

A Phase 1 study testing filgrastim, docetaxel and epirubicin hydrochloride in people with Breast Cancer and Neutropenia, run by NCIC Clinical Trials Group at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person 's immune system recover from the side effects of… Read more about this study

Who is it for?
Ages 16 to 120 years, women only
Conditions the study is for
Breast Cancer, Neutropenia
What is being tested?
filgrastim, docetaxel and epirubicin hydrochloride
How many people
50 participants
Where
6 sitesCanada
Study dates
12 Aug 1996to 21 Dec 2009
Phase
Phase 1
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 16 to 120 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Newly diagnosed or progressive metastatic disease with at least 1 metastatic target lesion No known clinical brain or leptomeningeal metastasis Phase I entry: Measurable and/or evaluable disease with an indicator lesion outside prior radiotherapy field Phase II entry: (closed as of 03/27/2000) Bidimensionally measurable disease with an indicator lesion outside prior radiotherapy field At least 1 x 1 cm on chest x-ray At least 2 x 2 cm on CT scan or ultrasound Skin lesion or node at least 1 x 1 cm No bone-only lesion Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 16 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than the upper limit of normal (ULN) AST/ALT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5.0 times ULN if AST/ALT normal) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: Left ventricular ejection fraction at least 50% at rest by MUGA or echocardiogram No congestive heart failure No angina pectoris (even if controlled) No myocardial infarction within the past year No uncontrolled arrhythmia No uncontrolled hypertension Other: No active infection No grade 2 or greater symptomatic peripheral neuropathy No significant neurologic or psychiatric disorder, including dementia or seizures No peptic ulcer, unstable diabetes mellitus, or other contraindication to dexamethasone No prior malignancy except nonmelanomatous skin cancer or excised carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Geographically accessible

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent supportive colony-stimulating factors (e.g., filgrastim (G -CSF)) (Prophylactic treatment during the second step of phase I allowed) Chemotherapy: Phase I patients: At least 12 months since prior adjuvant chemotherapy Prior neoadjuvant chemotherapy allowed Prior cumulative dose of doxorubicin no greater than 300 mg/m2 Prior cumulative dose of epirubicin no greater than 500 mg/m2 If epirubicin dose level at least 90 mg/m2: Prior cumulative dose of doxorubicin no greater than 200 mg/m2 Prior cumulative dose of epirubicin no greater than 300 mg/m2 Phase II patients: (closed as of 03/27/2000) No prior neoadjuvant or adjuvant chemotherapy regimen other than cyclophosphamide, methotrexate, and fluorouracil, or doxorubicin and cyclophosphamide given for a maximum of 4 courses All patients: No prior chemotherapy for metastatic disease No prior taxanes Endocrine therapy: Prior hormonal therapy in the adjuvant and/or metastatic setting allowed if subsequent disease progression No more than 2 prior hormonal therapy regimens for metastatic disease No concurrent corticosteroids (except for premedication or hypersensitivity reaction) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy (unless single fractions for palliation) Concurrent local palliative radiotherapy for control of bone pain or for other reasons with no curative intent allowed Concurrent whole-brain radiotherapy for brain metastasis allowed No concurrent radiotherapy to sole measurable lesion Surgery: Not specified Other: No other concurrent investigational drugs or anticancer therapy No concurrent preventive IV antibiotics

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites
  • Hotel Dieu de Montreal

    Montreal, Quebec, H2W 1T8

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Women's College Campus, Sunnybrook and Women's College Health Science Center

    Toronto, Ontario, M5S 1B6

Other trials in Canada

About this study

Official title: A Phase I/II Study of Docetaxel and Epirubicin as First-Line Therapy for Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person 's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and epirubicin with and without G-CSF in treating women with metastatic breast cancer.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of docetaxel in combination with epirubicin and filgrastim (G-CSF) as first-line therapy in women with metastatic breast cancer (phase II closed as of 03/27/2000). II. Determine the pharmacokinetic profile of docetaxel and epirubicin in these patients. III. Evaluate the toxicity of this regimen given at the recommended phase II dose. IV. Determine the response rate and duration of response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of epirubicin and docetaxel. Patients receive epirubicin IV over 15 minutes followed by docetaxel IV over 60 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 4-13. Treatment continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of epirubicin and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose in which at least 2 of 6 patients experience dose-limiting toxicity. Additional patients will be accrued to receive treatment at the recommended phase II dose (phase II closed as of 03/27/2000). Patients are followed at 1 month and then every 3 months for survival.

PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued within 4-5 months for the phase I portion of the study. A total of 15-30 patients will be accrued within 7-8 months for the phase II portion of the study (closed as of 03/27/2000).

Being tested
filgrastim, docetaxel, epirubicin hydrochloride
Keywords
stage IV breast cancer, recurrent breast cancer, neutropenia
Medical subject headings
Breast Neoplasms, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2004 (estimated)
  2. Study start12 Aug 1996
  3. Primary completion19 Jul 2005
  4. Study completion21 Dec 2009

Resources

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 1
Primary purpose
Treatment
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002866
Sponsor's protocol ID
MA15
Other IDs
CAN-NCIC-MA15, NCI-V96-1063, CDR0000065138
Status last verified
Mar 2020
First submitted
1 Nov 1999
Last updated
1 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, docetaxel and epirubicin hydrochloride in people with Breast Cancer and Neutropenia, run by NCIC Clinical Trials Group at 6 sites in Canada.

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: finished, as of the sponsor's last update on 1 Apr 2020. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 1 Apr 2020.

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