Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028873
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2002-01-04
Brief Title:
R101933 Combined With Chemotherapy in Treating Patients With Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
An EORTC-IDBBCECSG Phase II Study Evaluating The Role Of The Multi-Drug Resistance MDR Reversor R101933 In Patients With Taxane Refractory Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 use different ways to stop tumor cells from dividing so they stop growing or die Some tumors become resistant to chemotherapy drugs Combining R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor cells to be killed
PURPOSE Phase II trial to study the effectiveness of combining R101933 with either paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of combining R101933 with either paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES
Determine the activity of R101933 in combination with paclitaxel or docetaxel in terms of response to treatment and level of clinical benefit in patients with taxane-refractory metastatic breast cancer
Determine the safety of this regimen in these patients
Determine the acute side effects in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive R101933 IV over 1 hour immediately followed by paclitaxel IV over 3 hours or docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity Patients who have no disease progression after 7 courses may continue with treatment at the investigators discretion
Patients are followed every 6 weeks until disease progression
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study
Determine the activity of R101933 in combination with paclitaxel or docetaxel in terms of response to treatment and level of clinical benefit in patients with taxane-refractory metastatic breast cancer
Determine the safety of this regimen in these patients
Determine the acute side effects in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive R101933 IV over 1 hour immediately followed by paclitaxel IV over 3 hours or docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity Patients who have no disease progression after 7 courses may continue with treatment at the investigators discretion
Patients are followed every 6 weeks until disease progression
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study
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 |
|---|---|---|---|
| IDBBC-10003 | None | None | None |
| EORTC-16004 | None | None | None |
| ECSG-EORTC-16004 | None | None | None |