Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002721
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
1999-11-01
Brief Title:
Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER
Status:
COMPLETED
Status Verified Date:
2014-05
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of doxorubicin plus estramustine in treating patients with metastatic recurrent prostate cancer that does not respond to hormone therapy
PURPOSE Phase I trial to study the effectiveness of doxorubicin plus estramustine in treating patients with metastatic recurrent prostate cancer that does not respond to hormone therapy
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of weekly intravenous doxorubicin DOX that can be given in combination with oral estramustine EM in patients with metastatic prostate cancer refractory to treatment with hormonal agents II Assess the frequency of expression of the multidrug resistance phenotype in biopsy specimens from these patients III Assess the response to DOXEM in these patients
OUTLINE 2-Drug Combination Chemotherapy Doxorubicin DOX NSC-123127 Estramustine EM NSC-89199
PROJECTED ACCRUAL Three to 18 patients will be entered
OUTLINE 2-Drug Combination Chemotherapy Doxorubicin DOX NSC-123127 Estramustine EM NSC-89199
PROJECTED ACCRUAL Three to 18 patients will be entered
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-V96-0816 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064574 | REGISTRY | None | None |