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

December 16, 2014 updated by: Consorzio Oncotech

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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 Names:
  • Ixempra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic Complete Response (pCR)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Feasibility/Tolerability for an individual patient is defined as the absence of hematologic toxicities requiring dose reduction as per protocol
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorzio Oncotech

Investigators

  • Principal Investigator: Marco MV Venturini, Doctor, Ospedale Sacro Cuore - Dipartimento di Oncologia Medica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM9-NEO-ADIXERN

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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