Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107510
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2005-04-05
Brief Title:
Docetaxel Carboplatin and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Drugs used in chemotherapy such as docetaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer
PURPOSE This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel carboplatin and pegfilgrastim
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the rate of breast-conserving surgery in patients treated with this regimen
Determine the clinical response rate in patients treated with this regimen
Determine the feasibility of drug administration in terms of the percent of planned dose actually administered per course in patients treated with this regimen
Determine the proportion of patients with negative pathologic lymph node status after treatment with this regimen
Determine the proportion of patients with residual ductal carcinoma in situ after treatment with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Patients also receive pegfilgrastim subcutaneously on day 2 Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
No more than 6 weeks after completion of chemotherapy patients undergo definitive surgery
After completion of study therapy patients are followed every 6 months until disease progression and then annually for up to 5 years Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years
Primary
Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel carboplatin and pegfilgrastim
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the rate of breast-conserving surgery in patients treated with this regimen
Determine the clinical response rate in patients treated with this regimen
Determine the feasibility of drug administration in terms of the percent of planned dose actually administered per course in patients treated with this regimen
Determine the proportion of patients with negative pathologic lymph node status after treatment with this regimen
Determine the proportion of patients with residual ductal carcinoma in situ after treatment with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Patients also receive pegfilgrastim subcutaneously on day 2 Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
No more than 6 weeks after completion of chemotherapy patients undergo definitive surgery
After completion of study therapy patients are followed every 6 months until disease progression and then annually for up to 5 years Patients who do not complete all 4 courses of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years
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 |
|---|---|---|---|
| CDR0000420834 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02650 | REGISTRY | None | None |