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

March 30, 2020 updated by: NCIC Clinical Trials Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M5S 1B6
        • Women's College Campus, Sunnybrook and Women's College Health Science Center
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • Hotel Dieu de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 1996

Primary Completion (Actual)

July 19, 2005

Study Completion (Actual)

December 21, 2009

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 26, 2004

First Posted (Estimate)

April 27, 2004

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA15
  • CAN-NCIC-MA15
  • NCI-V96-1063
  • CDR0000065138 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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