A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer.
Condition: Women With Primary Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      TITLE: A Phase II Study of Dose Density Regimen with Fluorouracil, Epirubicin and
      Cyclophosphamide at Days 1, 4 Every 14 Days with Filgrastim Support followed by Weekly
      Paclitaxel in Women with Primary Breast Cancer.

      PROTOCOL CODE: IRST 174.05

      PHASE: II

      STUDY DESIGN: Pharmacological, open-label, prospective, not randomized, monocentric trial

      DESCRIPTION OF STUDY TREATMENT:

      FEC + filgrastim x 3 cycles q 14-21 days

      Day 1 and day 4 = FEC (FLUOROURACIL 500 mg/m2 IV infusion of 30 minutes + EPIRUBICIN 60 mg/m2
      IV infusion of 1 hour + CYCLOPHOSPHAMIDE 500 mg/m2 IV infusion of 30 minutes).

      From day 7 until hematological recovery = Filgrastim 300 microg s.c.

      After 21 days from the last FEC cycle = Paclitaxel 100 mg/m2 IV infusion of 1hour (weekly for
      8 cycles, at day 1).

      NUMBER OF SUBJECTS: in the first stage, 11 patients have been planned, with an additional 27
      patients to the second stage if at least 7 patients complete the planned treatment.

      OBJECTIVES

      Primary objective: this trial is designed to assess feasibility of the proposed regimen with
      regard to toxicity and deliverability. Tolerability is defined as absence of any grade 3 or
      higher nonhematologic toxicity (excluding alopecia, nausea/vomit, and bone pain, which might
      be a consequence of the administration of filgrastim). Deliverability is measured as the
      percentage of patients who complete the planned treatment.

      Secondary objectives:

        -  Relapse-free survival: measured from enrollment to the first date between date of
           documented relapse (or death) or date of last tumor assessment (if no documented
           relapse), or the date of last tumor assessment before the start of any further antitumor
           therapy not planned in the protocol.

        -  Overall survival: measured from enrollment to the date of death of any cause or last
           follow-up.

      CORRELATIVE/SPECIAL STUDIES: to evaluate retrospectively potential biomarkers of activity and
      toxicity of this regimen, blood and plasma samples until 15 mL each one will be collected at
      study entry, before first docetaxel administration and 3-4 weeks after last docetaxel
      administration. Moreover, a paraffin block or specimens of the primary tumor will be
      collected for biological studies.

      STATISTICAL CONSIDERATIONS: This trial is designed to assess feasibility of the proposed
      regimen with regard to toxicity and deliverability.

      Tolerability is defined as absence of any grade 3 or higher non-hematologic toxicity
      (excluding alopecia, nausea/vomit, and bone pain, which might be a consequence of the
      administration of filgrastim).

      A Simon two-stage design has been used with a 60% tolerability rate considered not promising
      and an 80% tolerability rate as promising, and probability of type I and type II errors has
      been set to be 0.10.

      In the first stage, 11 patients have been planned, with an additional 27 patients to the
      second stage if at least 7 patients complete the planned treatment. The regimen would be
      considered tolerable and worthy of further study if at the end of the trial 27 out 38
      patients complete the planned treatment.
    


Intervention name(s): FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Fluorouracil; Epirubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment