Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
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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 |
Biological: pegfilgrastim Drug: docetaxel Drug: epirubicin hydrochloride |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer |
- Toxic effects [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]Findings were presented at ASCO 2010
- Response (phase II) [ Time Frame: 12 years ] [ Designated as safety issue: No ]Response was presented at ASCO 2010. Duration of response will be analyzed in 2015
| Enrollment: | 93 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pegfilgrastim, docetaxel and epirubicin |
Biological: pegfilgrastim
Dose escalation schedule A&B = 6mg fixed dose once per cycle on day 2
Drug: docetaxel
Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2
Drug: epirubicin hydrochloride
Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Atlantic Health Sciences Corporation | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Ontario | |
| Odette Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Univ. Health Network-Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| CHA-Hopital Du St-Sacrement | |
| Quebec City, Quebec, Canada, G1S 4L8 | |
| Study Chair: | Maureen E. Trudeau, BSc, MA, MD, FRCPC | Edmond Odette Cancer Centre at Sunnybrook |
More Information
Additional Information:
Publications:
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00066443 History of Changes |
| Other Study ID Numbers: | MA22, CAN-NCIC-MA22, CDR0000316237 |
| Study First Received: | August 6, 2003 |
| Last Updated: | April 10, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by NCIC Clinical Trials Group:
|
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer inflammatory breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Inflammatory Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Epirubicin Docetaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013