- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066443
Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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: Approximately 90 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
-
-
New Brunswick
-
Saint John, New Brunswick, Canada, E2L 4L2
- Atlantic Health Sciences Corporation
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
-
Toronto, Ontario, Canada, M5G 2M9
- Univ. Health Network-Princess Margaret Hospital
-
-
Quebec
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Quebec City, Quebec, Canada, G1S 4L8
- CHA-Hopital Du St-Sacrement
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 core biopsies once prior to registration and core biopsies at 2 other timepoints 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pegfilgrastim, docetaxel and epirubicin
|
Dose escalation schedule A&B = 6mg fixed dose once per cycle on day 2
Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2
Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxic effects
Time Frame: 7 years
|
Findings were presented at ASCO 2010
|
7 years
|
Response (phase II)
Time Frame: 12 years
|
Response was presented at ASCO 2010.
Duration of response will be analyzed in 2015
|
12 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Maureen E. Trudeau, BSc, MA, MD, FRCPC, Toronto Sunnybrook Regional Cancer Centre
Publications and helpful links
General Publications
- Parissenti AM, Chapman JA, Kahn HJ, Guo B, Han L, O'Brien P, Clemons MP, Jong R, Dent R, Fitzgerald B, Pritchard KI, Shepherd LE, Trudeau ME. Association of low tumor RNA integrity with response to chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2010 Jan;119(2):347-56. doi: 10.1007/s10549-009-0531-x.
- Trudeau ME, Chapman JA, Guo B, Clemons MJ, Dent RA, Jong RA, Kahn HJ, Pritchard KI, Han L, O'Brien P, Shepherd LE, Parissenti AM. A phase I/II trial of epirubicin and docetaxel in locally advanced breast cancer (LABC) on 2-weekly or 3-weekly schedules: NCIC CTG MA.22. Springerplus. 2015 Oct 21;4:631. doi: 10.1186/s40064-015-1392-x. eCollection 2015.
- Parissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25.
- Pritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Inflammatory Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Epirubicin
Other Study ID Numbers
- MA22
- CAN-NCIC-MA22
- CDR0000316237 (Other Identifier: PDQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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