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

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, IPDSharing

    Re-verified, no change to tracked fields

    v42

  2. Notable

    Start date: Feb 25, 2003 to Nov 3, 2003

    Study Statusv41

  3. Minor

    Study Status, IPDSharing

    Re-verified, no change to tracked fields

    v40

  4. Notable

    Primary completion date: Jan 2014 to Jan 6, 2010

    Completion date: Jan 2014 to Jan 16, 2014; Start date: Feb 2003 to Feb 25, 2003; Publications: details revised at 1 of 4 entries

    Study Status, Oversight, IPDSharing, Referencesv39

  5. Minor

    Publications: details revised at 1 of 4 entries

    Study Status, Referencesv38

Show 36 earlier versions

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v37

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Primary completion date changed from estimate of Jun 2014 to Jan 2014; Study completion date changed from estimate of Dec 2014 to Jan 2014

    Study Statusv36

  3. Minor

    Completion date: Jun 2014 to Dec 2014

    Study Statusv35

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v34

  5. Minor

    Study arms: 0 to 1

    Study Status, Arms and Interventionsv33

  6. Minor

    Eligibility criteria expanded, about 3 words

    Study description shortened, about 2 words; Study sites revised (5)

    Show what changed: Eligibility criteria
    [...] -derived or polyethylene glycol products Willing to undergo 1 core biopsybiopsies once prior to registration and 2 core biopsies at 2 other timepoints while on study Geographically accessible for treatment and [...]
    Show what changed: Study description
    [...] or 1 year, and then annually thereafter. PROJECTED ACCRUAL: AApproximately total of 30-5090 patients will be accrued for this study.
    Show what changed: Study sites
    SaintAtlantic JohnHealth RegionalSciences HospitalCorporation Edmond Odette Cancer Centre Univ. atHealth Sunnybrook Network-Princess Margaret Hospital CHA-Hopital duDu SaintSt-Sacrement - Quebec

    Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv32

  7. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v31

  8. Notable

    Primary completion date: Dec 2009 to Jun 2014

    Trial status: Recruiting to Active, Not Recruiting; Enrollment target: estimated 50 to confirmed 93; Completion date: Jun 2014; and 1 more

    Show all 5 changes in this update
    • Notable Primary completion date: Dec 2009 to Jun 2014
    • Minor Trial status: Recruiting to Active, Not Recruiting
    • Minor Enrollment target: estimated 50 to confirmed 93
    • Minor Completion date: Jun 2014
    • Minor Site details revised at 5 of 5 sites

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Contacts/Locationsv30

  9. Notable

    Lead sponsor: Canadian Cancer Trials Group to NCIC Clinical Trials Group

    Publications: details revised at 1 of 4 entries

    Study Status, Sponsor/Collaborators, Referencesv29

  10. Minor

    Study sites: 6 to 5

    Study Status, Contacts/Locationsv28

  11. Minor

    Interventions: docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim (Drug) to docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim (Biological)

    Study Status, Arms and Interventionsv27

  12. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v26

  13. Minor

    Interventions: chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim… to docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim (Drug)

    Study Status, Arms and Interventionsv25

  14. Minor

    Study sites: 4 to 6

    Study Status, Contacts/Locationsv24

  15. Minor

    Primary completion date: Dec 2009

    Study Statusv23

  16. Minor

    Study Status

    Re-verified, no change to tracked fields

    v22

  17. Minor

    Interventions: biological therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy (Procedure)… to chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), docetaxel (Drug), epirubicin hydrochloride (Drug), pegfilgrastim…

    Study Status, Arms and Interventionsv21

  18. Minor

    Start date: Feb 2003

    Eligibility criteria expanded, about 2 words; Study description expanded, about 23 words

    Show what changed: Eligibility criteria
    [...] e breast, meeting any of the following criteria: T4, NX, M0 Any T, N2-N3, M0 Inflammatory breast cancer (redness over at least [...]
    Show what changed: Study description
    [...] st 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. [...] ce dose-limiting toxicity. Phase II: Group 1 (21-day regimen) (closed to accrual as of 5/10/06): Patients receive treatment as in phase I with epirubicin and docetaxel at the MTDrecommended Phase II dose. Group 2 (14-day regimen): Patients receive treatment as in phase I with epirubicin and docetaxel at the MTDrecommended Phase II dose. Patients are followed at 1 month, every 3 months for 1 yea [...]

    Study Status, Study Description, Eligibilityv20

  19. Minor

    Study sites revised (4)

    Show what changed: Study sites
    TorontoEdmond Sunnybrook RegionalOdette Cancer Centre at Sunnybrook Health Sciences Centre

    Study Status, Contacts/Locationsv19

  20. Minor

    Study Status

    Re-verified, no change to tracked fields

    v18

  21. Notable

    Primary endpoints: 5 to 2

    Show what changed: Primary endpoints
    ClinicalResponse and pathological response rate and duration of response Drug sensitivity and resistance in patients treated with this regimen Maximum tolerated dose and recommended (phase II) Toxic dose of docetaxel and epirubicin Prognostic and predictive markers Toxicityeffects

    Study Status, Outcome Measures, Eligibilityv17

  22. Minor

    Study Status, Eligibility

    v16

  23. Minor

    Site contacts updated at 1 of 4 sites

    Study Status, Contacts/Locationsv15

  24. Minor

    Study Status

    Re-verified, no change to tracked fields

    v14

  25. Minor

    Study Status, Outcome Measures

    v13

  26. Minor

    Study Status, Outcome Measures

    v12

  27. Minor

    Enrollment target: 50

    Study description expanded, about 26 words

    Show what changed: Study description
    [...] icenter, 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 [...] eive additional therapy at the discretion of the physician. Group 2 (14-day regimen): Patients receive epirubicin IV over 15 minutes and docetaxel [...] of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II: Group 1 (21-day regimen): Patients receive treatment as in phase I with epirubicin and docetaxel at the MTD. Group 2 (14-day regimen): Patients receive treatment as in phase I with epirubicin an [...]

    Study Identification, Study Status, Study Description, Conditions, Study Designv11

  28. Minor

    Study sites revised (4)

    Show what changed: Study sites
    Hopital du Saint-Sacrement, - Quebec

    Study Status, Contacts/Locationsv10

  29. Minor

    Study Status

    Re-verified, no change to tracked fields

    v9

  30. Minor

    Site contacts updated at 1 of 4 sites

    Study Status, Contacts/Locationsv8

  31. Minor

    Study sites revised (4)

    Show what changed: Study sites
    Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

    Study Status, Contacts/Locationsv7

  32. Minor

    Eligibility criteria expanded, about 3 words

    Study description expanded, about 54 words

    Show what changed: Eligibility criteria
    [...] e of metastatic disease by chest x-ray, abdominal ultrasound, or CT scan and bone scan Diagnosed within the past 48 weeks Hormone receptor status: Not specified PATIENT CHARAC [...]
    Show what changed: Study description
    [...] women with locally advanced or inflammatory breast cancer. (phasePhase I, group 1 closed to accrual as of 129/2913/0504) Determine the toxicity of this regimen in these patients. [...] eive additional therapy at the discretion of the physician. 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 after 8 courses may [...] Cohorts of 3-6 patients receive escalating doses of epirubic [...] [...]

    Study Identification, Study Status, Study Description, Eligibilityv6

  33. Minor

    Interventions: biological response modifier therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy… to biological therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy (Procedure)…

    Study Status, Arms and Interventionsv5

  34. Minor

    Interventions: biological response modifier therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy… to biological response modifier therapy (Procedure), chemotherapy (Procedure), colony-stimulating factor therapy (Procedure), cytokine therapy…

    Study Status, Conditions, Arms and Interventionsv4

  35. Minor

    Study sites revised (4)

    Show what changed: Study sites
    Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

    Study Identification, Study Status, Contacts/Locationsv3

  36. Minor

    Study sites: 2 to 4

    Study Identification, Study Status, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00066443
Lead Sponsor NCIC Clinical Trials Group
Conditions Breast Cancer
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov