Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038246
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2002-05-29
Brief Title:
Study of Paclitaxel Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Paclitaxel Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma AI-PCa
Status:
COMPLETED
Status Verified Date:
2018-10
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:
The three study drugs Thalidomide Taxol and Estramustine used in this study are all chemotherapy drugs used in shrinking the cancer
Detailed Description:
1 Evaluate the maximum tolerated dose of oral daily thalidomide along with Paclitaxel 100 mgm2 as a 3-hour infusion weekly 2 every 21 days and oral estramustine phosphate 140 mg by mouth three timesday 5 days per week 2 weeks every 21 days for patients with metastatic androgen-independent prostate carcinoma
2 Evaluate the efficacy of this regimen for patients with metastatic Androgen-Independent Prostate Cancer who failed up to two prior non-paclitaxel containing chemotherapy regimens as measured by
2A The objective response rate and prostate-specific antigen PSA response rate of the combination treatment in patients with AI-PCa progressing after chemotherapy
2B Secondary endpoints calculate time to disease progression effect on performance status analgesic consumption and survival
3 To evaluate the toxicity of the combination treatment in patients with metastatic AI-PCa progressing after chemotherapy
2 Evaluate the efficacy of this regimen for patients with metastatic Androgen-Independent Prostate Cancer who failed up to two prior non-paclitaxel containing chemotherapy regimens as measured by
2A The objective response rate and prostate-specific antigen PSA response rate of the combination treatment in patients with AI-PCa progressing after chemotherapy
2B Secondary endpoints calculate time to disease progression effect on performance status analgesic consumption and survival
3 To evaluate the toxicity of the combination treatment in patients with metastatic AI-PCa progressing after chemotherapy
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