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.

• Status: Completed
• Trial end date: 2014-07-01

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.

• Phase: Phase 2

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Fluorouracil; Lenograstim; Paclitaxel