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

NCT00751868 | Completed Phase 2 DMC

• 1 other identifier: GIM9-NEO-ADIXERN
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR)

  one year

Secondary Outcomes (1)

• Feasibility/Tolerability for an individual patient is defined as the absence of hematologic toxicities requiring dose reduction as per protocol

  one year

Study Arms (1)

ARM 1

EXPERIMENTAL

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

Interventions

Ixabepilone DRUG

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)

Also known as: Ixempra

ARM 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Signed Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorzio Oncotech: lead

Study Sites (15)

Azienza Osped.Treviglio - Caravaggio

Treviglio, BG, 24047, Italy

Location

Azienda Ospedaliera G. Rummo

Benevento, BN, 82100, Italy

Location

Ospedale Civile di Campobasso - A. Cardarelli

Campabasso, CB, 86100, Italy

Location

Ospedale civile Renzetti di Lanciano

Lanciano, CH, 66034, Italy

Location

Azienda Ospedaliera S. Anna

Como, CO, 22100, Italy

Location

Azienda Ospedaliera Nesina Garibaldi

Catania, CT, 95124, Italy

Location

I.S.T. - Istituto Nazionale per la Ricerca sul Cancro

Genova, GE, 16131, Italy

Location

Presidio Ospedaliero di Macerata

Mecerata, MC, 62100, Italy

Location

I.R.C.C.S. Multimedica - Casa di Cura Accreditata

Sesto San Giovanni, Milano, 20099, Italy

Location

Azienda Ospedaliera R. Silvestrini

Perugia, PG, 06132, Italy

Location

Istituto Regina Elena

Roma, Roma, 00100, Italy

Location

Azienda Ospedaliera SS. Annunziata

Sassari, SS, 07100, Italy

Location

Ospedale S. Cuore Don Calabria

Negrar, Verona, 37024, Italy

Location

Ist. Nazionale per lo Studio e la Cura dei Tumori - Fondazione Pascale

Napoli, 80131, Italy

Location

Università Federico II

Napoli, 80131, Italy

Location

Related Publications (1)

• Clavarezza M, Bordonaro R, Daniele B, Ferrandina G, Barni S, Turazza M, Coati F, De Matteis A, De Placido S, Cognetti F, Olmeo NA, Carrozza F, Bruzzi P, Del Mastro L; Gruppo Italiano Mammella. Dose-dense FEC followed by dose-dense ixabepilone as neoadjuvant treatment for breast cancer patients: a feasibility study. Oncologist. 2013;18(8):924-5. doi: 10.1634/theoncologist.2013-0222. Epub 2013 Aug 12.

  PMID: 23939283 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marco MV Venturini, Doctor

  Ospedale Sacro Cuore - Dipartimento di Oncologia Medica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

IT (15)