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Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008

Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066443
  Purpose

RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim 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 combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: pegfilgrastim
Phase I
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

Drug Information available for:   Docetaxel    Epirubicin hydrochloride    Epirubicin    Pegfilgrastim   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxic effects [ Designated as safety issue: Yes ]
  • Response (phase II) [ Designated as safety issue: No ]

Estimated Enrollment:   50
Study Start Date:   February 2003
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of docetaxel and epirubicin when given with pegfilgrastim in women with locally advanced or inflammatory breast cancer. (Phase I, group 1 closed to accrual as of 9/13/04 and Phase II, group 1 closed to accrual as of 5/10/06)
  • Determine the toxicity of this regimen in these patients.
  • Determine the clinical and pathological response rate and duration of response in patients treated with this regimen.
  • Determine drug sensitivity and resistance in patients treated with this regimen.
  • Determine prognostic and predictive markers in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of docetaxel and epirubicin.

  • Phase I:

Group 1 (21-day regimen) (closed to accrual as of 09/13/04): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 6 courses may receive additional therapy at the discretion of the physician.

Group 2 (14-day regimen): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 8 courses may receive additional therapy at the discretion of the physician.

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 at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II:

Group 1 (21-day regimen) (closed to accrual as of 5/10/06): Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose.

Group 2 (14-day regimen): Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose.

Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria:

    • T4, NX, M0
    • Any T, N2-N3, M0
    • Inflammatory breast cancer (redness over at least one-third of the breast), M0
  • No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan
  • Diagnosed within the past 8 weeks
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin less than upper limit of normal (ULN)
  • Must meet criteria for 1 of the following:

    • ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN
    • ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • Resting LVEF normal by MUGA or echocardiogram
  • No congestive heart failure
  • No angina pectoris
  • No myocardial infarction within the past year
  • No uncontrolled hypertension
  • No uncontrolled arrhythmias

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
  • No symptomatic peripheral neuropathy grade 2 or greater
  • No active infection
  • No history of significant neurological or psychiatric disorders, including dementia or seizures
  • No peptic ulcer
  • No unstable diabetes mellitus
  • No contraindication to dexamethasone
  • No known sensitivity to E. coli-derived or polyethylene glycol products
  • Willing to undergo 1 core biopsy prior to registration and 2 core biopsies while on study
  • Geographically accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy for breast cancer

Chemotherapy

  • No prior chemotherapy for breast cancer

Endocrine therapy

  • No prior hormonal therapy for breast cancer
  • No concurrent corticosteroids except for premedication or hypersensitivity reaction
  • No concurrent oral contraception

Radiotherapy

  • No prior radiotherapy for breast cancer

Surgery

  • No prior surgery for breast cancer other than biopsy

Other

  • No prior systemic therapy for breast cancer
  • No other concurrent investigational drugs or anticancer treatment
  • No concurrent preventative IV antibiotics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066443

Locations
Canada, Manitoba
CancerCare Manitoba     Recruiting
      Winnipeg, Manitoba, Canada, R3E 0V9
      Contact: Debjani Grenier     204-235-3394        
Canada, New Brunswick
Saint John Regional Hospital     Recruiting
      Saint John, New Brunswick, Canada, E2L 4L2
      Contact: Margot Burnell     506-648-6884        
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook     Recruiting
      Toronto, Ontario, Canada, M4N 3M5
      Contact: Maureen E. Trudeau     416-480-5145        
Princess Margaret Hospital     Recruiting
      Toronto, Ontario, Canada, M5G 2M9
      Contact: Mark Clemons     416-946-4543        
St. Michael's Hospital - Toronto     Recruiting
      Toronto, Ontario, Canada, M5B 1W8
      Contact: Rashida Haq     416-864-5912        
Canada, Quebec
Hopital du Saint-Sacrement - Quebec     Recruiting
      Quebec City, Quebec, Canada, G1S 4L8
      Contact: Louise Provencher     418-682-7511        

Sponsors and Collaborators
National Cancer Institute of Canada

Investigators
Study Chair:     Maureen E. Trudeau, BSc, MA, MD, FRCPC     Edmond Odette Cancer Centre at Sunnybrook    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000316237, CAN-NCIC-MA22
First Received:   August 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00066443
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer  
stage IIIB breast cancer  
stage IIIC breast cancer  
inflammatory breast cancer  

Study placed in the following topic categories:
Docetaxel
Inflammatory breast cancer
Skin Diseases
Breast Neoplasms
Epirubicin
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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