FEC With G-CSF Support Followed by Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in BC (GIM9)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Consorzio Oncotech
ClinicalTrials.gov Identifier:
NCT00751868
First received: September 11, 2008
Last updated: December 16, 2014
Last verified: December 2014
  Purpose

The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of G-CSF.

To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due to toxicity of the regimen.


Condition Intervention Phase
Breast Cancer
Drug: Ixabepilone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NEO-ADIXERN (NEO-ADjuvant IXabepilone in Breast Cancer). A Feasibility Study of Dose-dense FEC With G-CSF Support Followed by Dose-dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Consorzio Oncotech:

Primary Outcome Measures:
  • Pathologic Complete Response (pCR) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility/Tolerability for an individual patient is defined as the absence of hematologic toxicities requiring dose reduction as per protocol [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM 1
FEC e Ixabepilone. A goal of 48 patients will be enrolled in this study by 16 Italian centres of the GIM (Gruppo Italiano Mammella) Group. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled in the study
Drug: Ixabepilone
Ixabepilone is administered as 3-hour intravenous infusion (iv) at the dose of 40 mg/mq, every 14 days for 4 cycles (with G-CSF support), sequentially to Fluorouracil 600 mg/mq as intravenous (iv) infusion, Epirubicin 90 mg/mq as intravenous (iv) bolus and Cyclophosphamide 600 mg/mq as intravenous (iv) infusion every 14 days for 4 cycles (with G-CSF support)
Other Name: Ixempra

Detailed Description:

Estrogen receptor negative breast cancer may be defined as distinct biologic subtype disease, more aggressive with a typical molecular portrait. [30] This subtype seems to have a poor prognosis and poor treatment options because these patients are not candidate to hormonal therapy. Novel treatment strategies focusing upon this subtype are necessary in the future. [31] There are reports of clinical benefit in estrogen receptor negative patients treated with dose-dense chemotherapy (see background CALGB 9741 and MIG-1 study). In the CALGB 9741 study, patients randomized to receive dose-dense regimens experienced severe toxicities during paclitaxel treatment leading to dose reduction in 7% and 5%respectively.

Ixabepilone has shown consistent activity and an acceptable safety profile in patients with all stages breast cancer. This phase II study evaluate the feasibility of dose-dense Ixabepilone (4 cycles) given sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) all given every 14 days with the support of Filgrastim as neo-adjuvant treatment for ER-negative breast cancer patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documented diagnosis of breast cancer by incisional biopsy
  • Clinical T>=2
  • Females age >= 18 and <= 70 years
  • ECOG performance status 0-1
  • No prior treatment for breast cancer excluding therapy for DCIS
  • Subjects with hormone replacement therapy are eligible if this therapy is discontinued at least 2 weeks before starting therapy
  • Neutrophils > 2x109/L, Hgb > 9 g/dL, platelets > 100x109/L
  • Total bilirubin < 1 time the upper limit of normal (ULN) of the Institutional normal values and AST and/or ALT < 2.5 ULN, alkaline phosphatase < 2.5 ULN
  • Serum creatinine < 1.5 times the upper limit of normal (ULN)
  • Normal cardiac function (normal ECG required in all patients, normal ECG and MUGA or Echocardiography with EF only in HER-2 positive patients)
  • Negative pregnancy test prior to inclusion in the study (if potentially childbearing)
  • Signed Informed consent

Exclusion Criteria:

  • Prior or current history of ipsilateral or controlateral breast invasive cancer. A past or current history of ipsilateral ductal carcinoma in situ or ipsilateral/controlateral lobular neoplasia in situ are not an exclusion criteria as well as a controlateral ductal carcinoma in situ removed by mastectomy
  • Inflammatory breast cancer
  • Metastatic breast cancer (M1)
  • Histology other than adenocarcinoma of the breast
  • Male patients
  • Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
  • Patients unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational drug
  • History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
  • Symptomatic peripheral neuropathy > grade 1 according to the NCI CTC
  • Other serious illness or medical condition:
  • Congestive hearth failure or angina pectoris even if it is medically controlled. In particular, Ejection Fraction (EF) below the Institutional normal value for MUGA Fraction (EF) below the Institutional normal value for MUGA, or below 50% for ECHO
  • Previous history of myocardial infarction uncontrolled, high-risk ipertension or arrhythmia
  • History of significant neurological or psychiatric disorders including dementia or seizures
  • Active infection, active peptic ulcer, unstable diabetes mellitus or contraindications for the use of steroids
  • History of previous or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry
  • Prior severe HSR to agents containing Cremophor EL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751868

Locations
Italy
Azienza Osped.Treviglio - Caravaggio
Treviglio, BG, Italy, 24047
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy, 82100
Ospedale Civile di Campobasso - A. Cardarelli
Campabasso, CB, Italy, 86100
Ospedale civile Renzetti di Lanciano
Lanciano, CH, Italy, 66034
Azienda Ospedaliera S. Anna
Como, CO, Italy, 22100
Azienda Ospedaliera Nesina Garibaldi
Catania, CT, Italy, 95124
I.S.T. - Istituto Nazionale per la Ricerca sul Cancro
Genova, GE, Italy, 16131
Presidio Ospedaliero di Macerata
Mecerata, MC, Italy, 62100
I.R.C.C.S. Multimedica - Casa di Cura Accreditata
Sesto San Giovanni, Milano, Italy, 20099
Azienda Ospedaliera R. Silvestrini
Perugia, PG, Italy, 06132
Azienda Ospedaliera SS. Annunziata
Sassari, SS, Italy, 07100
Ospedale S. Cuore Don Calabria
Negrar, Verona, Italy, 37024
Ist. Nazionale per lo Studio e la Cura dei Tumori - Fondazione Pascale
Napoli, Italy, 80131
Università Federico II
Napoli, Italy, 80131
Istituto Regina Elena
Roma, Italy, 00100
Sponsors and Collaborators
Consorzio Oncotech
Investigators
Principal Investigator: Marco MV Venturini, Doctor Ospedale Sacro Cuore - Dipartimento di Oncologia Medica
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Consorzio Oncotech
ClinicalTrials.gov Identifier: NCT00751868     History of Changes
Other Study ID Numbers: GIM9-NEO-ADIXERN 
Study First Received: September 11, 2008
Last Updated: December 16, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Consorzio Oncotech:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2016