Viewing Study NCT00001384



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001384
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: A Pilot Trial of AC Adriamycin Cyclophosphamide Chemotherapy With G-CSF Granulocyte Colony-Stimulating Factor Followed by Infusional Taxol Paclitaxel as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: A Pilot Trial of AC Adriamycin Cyclophosphamide Chemotherapy With G-CSF Granulocyte Colony-Stimulating Factor Followed by Infusional Taxol Paclitaxel as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients
Status: COMPLETED
Status Verified Date: 2000-04
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: This is a pilot feasibility trial of AC Adriamycin cyclophosphamide chemotherapy with G-CSF filgrastim followed by infusional Taxol paclitaxel as adjuvant treatment for patients with high risk stage II and stage III breast cancer Cycles will be 14 days in duration After 3 fourteen day cycles of AC with filgrastim patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles
Detailed Description: This is a pilot feasibility trial of AC Adriamycin Registered Trademark cyclophosphamide chemotherapy with G-CSF filgrastim followed by infusional Taxol Registered Trademark paclitaxel as adjuvant treatment for patients with high risk stage II and stage III breast cancer Cycles will be 14 days in duration After 3 fourteen day cycles of AC with filgrastim patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles

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
Secondary IDs
Secondary ID Type Domain Link
94-C-0145 None None None