Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002826
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
1999-11-01
Brief Title:
Drug Resistance Inhibition in Treating Women With Recurrent or Metastatic Breast Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST
Status:
COMPLETED
Status Verified Date:
2023-06
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 Some tumors become resistant to chemotherapy drugs Combining PSC 833 with a chemotherapy drug may reduce resistance to the drug and allow the tumor cells to be killed
PURPOSE Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating women who have recurrent or metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating women who have recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES I Evaluate the antitumor activity as measured by frequency of objective response and time to progression of the multidrug resistance modulator PSC 833 in combination with paclitaxel in women with recurrent or metastatic breast cancer II Describe the toxicity of this regimen
OUTLINE All patients receive PSC 833 by mouth every 6 hours for a total of 12 doses Paclitaxel is infused over 3 hours after the 5th dose of PSC 833 Treatment is repeated every 3 weeks in stable and responding patients PSC 833 must not be mixed with grapefruit juice Growth factors may be used at the discretion of the investigator Patients are followed every 3 months for the first two years then every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL It is anticipated that approximately 36 patients will be entered over 24 months if there are at least 6 responses in the first 17 patients
OUTLINE All patients receive PSC 833 by mouth every 6 hours for a total of 12 doses Paclitaxel is infused over 3 hours after the 5th dose of PSC 833 Treatment is repeated every 3 weeks in stable and responding patients PSC 833 must not be mixed with grapefruit juice Growth factors may be used at the discretion of the investigator Patients are followed every 3 months for the first two years then every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL It is anticipated that approximately 36 patients will be entered over 24 months if there are at least 6 responses in the first 17 patients
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 |
|---|---|---|---|
| E-1195 | None | None | None |