Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176527
Status:
TERMINATED
Last Update Posted:
2009-12-11
First Post:
2005-09-12
Brief Title:
Isotretinoin Interferon Alfa-2b Docetaxel and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Phase II Trial of 13-Cis Retinoic Acid Alpha Interferon Taxotere and Estramustine RITE for the Treatment of Hormone Refractory Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
accrual goal met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Isotretinoin may help prostate cancer cells become more like normal cells and to grow and spread more slowly Interferon alfa-2b may interfere with the growth of tumor cells Drugs used in chemotherapy such as docetaxel and estramustine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine may kill more tumor cells
PURPOSE This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy
PURPOSE This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with docetaxel and estramustine works in treating patients with metastatic prostate cancer that did not respond to hormone therapy
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in terms of change in measurable disease or prostate-specific antigen levels in patients with hormone-refractory metastatic prostate cancer treated with isotretinoin recombinant interferon alfa-2b docetaxel and estramustine phosphate sodium
Secondary
Determine the effect of this regimen on bcl-2 family proteins in peripheral blood mononuclear cell samples obtained from these patients
OUTLINE Patients receive oral isotretinoin once daily on days 1-4 recombinant interferon alfa-2b subcutaneously once daily on days 1-4 oral estramustine phosphate sodium three times daily on days 1-5 and docetaxel IV over 1 hour on day 2 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2 3 or 4 and analyzed for bcl-2 protein by IHC and electrophoresis
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the response rate in terms of change in measurable disease or prostate-specific antigen levels in patients with hormone-refractory metastatic prostate cancer treated with isotretinoin recombinant interferon alfa-2b docetaxel and estramustine phosphate sodium
Secondary
Determine the effect of this regimen on bcl-2 family proteins in peripheral blood mononuclear cell samples obtained from these patients
OUTLINE Patients receive oral isotretinoin once daily on days 1-4 recombinant interferon alfa-2b subcutaneously once daily on days 1-4 oral estramustine phosphate sodium three times daily on days 1-5 and docetaxel IV over 1 hour on day 2 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Peripheral blood mononuclear cells are acquired via blood draw at baseline and on days 2 3 or 4 and analyzed for bcl-2 protein by IHC and electrophoresis
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| CINJ080107-3850 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |