Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021372
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2001-07-11
Brief Title:
Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Study of Paclitaxel and Estramustine Phosphate in Patients With Relapsed Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-07
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel and estramustine in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining paclitaxel and estramustine in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the response rate time to treatment failure and overall survival of patients with relapsed or refractory non-Hodgkins lymphoma treated with paclitaxel and estramustine II Determine the toxicity of this regimen in this patient population
OUTLINE Patients receive oral estramustine 2-3 times daily on days 1-3 and paclitaxel IV over 1 hour on day 2 on weeks 1-6 Treatment repeats every 8 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity Patients achieving a complete or partial response continue therapy for at least 3 courses or for 1 course after achieving maximum response Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study
OUTLINE Patients receive oral estramustine 2-3 times daily on days 1-3 and paclitaxel IV over 1 hour on day 2 on weeks 1-6 Treatment repeats every 8 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity Patients achieving a complete or partial response continue therapy for at least 3 courses or for 1 course after achieving maximum response Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-35 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 |
|---|---|---|---|
| NCI-G01-1986 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-96026 | None | None | None |