Clinical Trial: Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer

Brief Summary:

RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.


Detailed Summary:

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of docetaxel and epirubicin when given with pegfilgrastim in women with locally advanced or inflammatory breast cancer. (Phase I, group 1 closed to accrual as of 9/13/04 and Phase II, group 1 closed to accrual as of 5/10/06)
  • Determine the toxicity of this regimen in these patients.
  • Determine the clinical and pathological response rate and duration of response in patients treated with this regimen.
  • Determine drug sensitivity and resistance in patients treated with this regimen.
  • Determine prognostic and predictive markers in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of docetaxel and epirubicin.

  • Phase I:

Group 1 (21-day regimen) (closed to accrual as of 09/13/04): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 6 courses may receive additional therapy at the discretion of the physician.

Group 2 (14-day regimen): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response aft
Sponsor: NCIC Clinical Trials Group

Current Primary Outcome:

  • Toxic effects [ Time Frame: 7 years ]
    Findings were presented at ASCO 2010
  • Response (phase II) [ Time Frame: 12 years ]
    Response was presented at ASCO 2010. Duration of response will be analyzed in 2015


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Canadian Cancer Trials Group

Dates:
Date Received: August 6, 2003
Date Started: February 2003
Date Completion:
Last Updated: November 2, 2015
Last Verified: January 2014