Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256360
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2005-11-16
Brief Title:
Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil Epirubicin Plus Cyclophosphamide FEC and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
A Randomized Phase II Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil Epirubicin Plus Cyclophosphamide FEC and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The rationale of this randomized phase II study is to investigate the feasibility of sequenced densified FEC and docetaxel based regimens in patients with primary operable high-risk breast cancer Several phase III and phase II clinical trials showed the benefits of dose-dense therapy Q2W over conventional treatment in breast cancer lymphoma and SCLC The aim of the study is also to demonstrate that further shortening of treatment interval from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patients safety The results of this randomized phase II study should serve as a basis for follow-up randomized phase III trial comparing conventional versus densified sequential FEC and docetaxel based regimens
Detailed Description:
Arm A
The three cycles of conventional FEC followed by three cycles of docetaxel regimen will be given at the following doses
Fluorouracil 500 mgm² by iv bolus or infusion Epirubicin 100 mgm² by 30 minutes iv infusion and Cyclophosphamide 500 mgm² by iv bolus or infusion followed by docetaxel 100 mgm2 iv infusion All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors
Pegfilgrastim is only allowed in secondary prophylaxis febrile neutropenia or prolonged grade IV neutropenia In the event of febrile neutropenia or prolonged grade IV neutropenia pegfilgrastim or filgrastim is given for treatment and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy
The total duration of treatment is 18 weeks
Arm B
The three cycles of conventional docetaxel followed by three cycles of FEC regimen will be given at the following doses
Docetaxel 100 mgm2 iv infusion followed by Fluorouracil 500 mgm² by iv bolus or infusion Epirubicin 100 mgm² by 30 minutes iv infusion and Cyclophosphamide 500 mgm² by iv bolus or infusion All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors
Pegfilgrastim is only allowed in secondary prophylaxis febrile neutropenia or prolonged grade IV neutropenia In the event of febrile neutropenia or prolonged grade IV neutropenia pegfilgrastim or filgrastim is given for treatment and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy
The total duration of treatment is 18 weeks
Arm C
The four cycles of dose-dense FEC followed by four cycles dose-dense docetaxel regimen will be given at the following doses
Fluorouracil 375 mgm² by iv bolus or infusion Epirubicin 75 mgm² by 30 minutes iv infusion and Cyclophosphamide 375 mgm² by iv bolus or infusion followed by docetaxel 75 mgm2 FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle and docetaxel will be given on Day 1 of each 14-day cycle
Pegfilgrastim Neulasta fixed dose of 6 mg 06 mL of a 10 mgmL solution as a single subcutaneous injection will be given in on Day 2 of each study cycle
The total duration of treatment is 14 weeks
Arm D
The four cycles of dose-dense docetaxel followed by four cycles dose-dense FEC regimen will be given at the following doses
Docetaxel 75 mgm² followed Fluorouracil 375 mgm² by iv bolus or infusion Epirubicin 75 mgm² by 30 minutes iv infusion and Cyclophosphamide 375 mgm² by iv bolus or infusion Docetaxel will be given on Day 1 of each 14-day cycle and FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle
Pegfilgrastim Neulasta fixed dose of 6 mg 06 mL of a 10 mgmL solution as a single subcutaneous injection will be given on Day 2 of each study cycle
The total duration of treatment is 14 weeks
The three cycles of conventional FEC followed by three cycles of docetaxel regimen will be given at the following doses
Fluorouracil 500 mgm² by iv bolus or infusion Epirubicin 100 mgm² by 30 minutes iv infusion and Cyclophosphamide 500 mgm² by iv bolus or infusion followed by docetaxel 100 mgm2 iv infusion All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors
Pegfilgrastim is only allowed in secondary prophylaxis febrile neutropenia or prolonged grade IV neutropenia In the event of febrile neutropenia or prolonged grade IV neutropenia pegfilgrastim or filgrastim is given for treatment and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy
The total duration of treatment is 18 weeks
Arm B
The three cycles of conventional docetaxel followed by three cycles of FEC regimen will be given at the following doses
Docetaxel 100 mgm2 iv infusion followed by Fluorouracil 500 mgm² by iv bolus or infusion Epirubicin 100 mgm² by 30 minutes iv infusion and Cyclophosphamide 500 mgm² by iv bolus or infusion All drugs will be administered intravenously on Day 1 of each 21-day cycle without support of growth factors
Pegfilgrastim is only allowed in secondary prophylaxis febrile neutropenia or prolonged grade IV neutropenia In the event of febrile neutropenia or prolonged grade IV neutropenia pegfilgrastim or filgrastim is given for treatment and pegfilgrastim should be further administered on day 2 of each subsequent cycle of chemotherapy
The total duration of treatment is 18 weeks
Arm C
The four cycles of dose-dense FEC followed by four cycles dose-dense docetaxel regimen will be given at the following doses
Fluorouracil 375 mgm² by iv bolus or infusion Epirubicin 75 mgm² by 30 minutes iv infusion and Cyclophosphamide 375 mgm² by iv bolus or infusion followed by docetaxel 75 mgm2 FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle and docetaxel will be given on Day 1 of each 14-day cycle
Pegfilgrastim Neulasta fixed dose of 6 mg 06 mL of a 10 mgmL solution as a single subcutaneous injection will be given in on Day 2 of each study cycle
The total duration of treatment is 14 weeks
Arm D
The four cycles of dose-dense docetaxel followed by four cycles dose-dense FEC regimen will be given at the following doses
Docetaxel 75 mgm² followed Fluorouracil 375 mgm² by iv bolus or infusion Epirubicin 75 mgm² by 30 minutes iv infusion and Cyclophosphamide 375 mgm² by iv bolus or infusion Docetaxel will be given on Day 1 of each 14-day cycle and FEC regimen will be administered intravenously on Day 1 of each 10-11-day cycle
Pegfilgrastim Neulasta fixed dose of 6 mg 06 mL of a 10 mgmL solution as a single subcutaneous injection will be given on Day 2 of each study cycle
The total duration of treatment is 14 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None