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A Feasibility Study of Dose-Dense FEC With G-CSF Support Followed by Dose-Dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in ER-Negative Breast Cancer (GIM9)
This study is not yet open for participant recruitment.
Verified by Consorzio Oncotech, September 2008
Sponsored by: Consorzio Oncotech
Information provided by: Consorzio Oncotech
ClinicalTrials.gov Identifier: NCT00751868
  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 II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Cyclophosphamide Ixabepilone Granulocyte colony-stimulating factor Fluorouracil Epirubicin hydrochloride Epirubicin Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: NEO-ADIXERN (NEO-ADjuvant IXabepilone in ER-Negative 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 ER-Negative Breast Cancer

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 ]

Estimated Enrollment: 48
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documented diagnosis of breast cancer by incisional biopsy
  • Clinical T>=2
  • ER negative breast cancer, independently from PgR and HER2 status
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751868

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

Responsible Party: Ospedale S. Cuore Don Calabria - Negrar Verona ( Marco Venturini )
Study ID Numbers: GIM9-NEO-ADIXERN
Study First Received: September 11, 2008
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00751868  
Health Authority: Italy: Ministry of Health

Keywords provided by Consorzio Oncotech:
breast cancer
Clinical T score >=2
ER negative breast cancer, independently from PgR and HER2 status
Females between 18 and 70 years
ECOG performance status 0-1
No prior treatment for breast cancer excluding therapy for DCIS
Histological documented diagnosis of breast cancer by incisional biopsy

Study placed in the following topic categories:
Naphazoline
Oxymetazoline
Skin Diseases
Guaifenesin
Phenylephrine
Fluorouracil
Epothilones
Breast Neoplasms
Phenylpropanolamine
Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009