Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003084
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Phase II Trial of TaxolVP-16Estramustine vs KetoconazoleDoxorubicinVinblastineEstramustine in Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel etoposide and estramustine as compared with ketoconazole plus doxorubicin vinblastine and estramustine in treating patients with prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel etoposide and estramustine as compared with ketoconazole plus doxorubicin vinblastine and estramustine in treating patients with prostate cancer
Detailed Description:
OBJECTIVES I Determine the clinical benefit of two combination chemotherapy regimens paclitaxel etoposide and estramustine vs ketoconazole doxorubicin vinblastine and estramustine in patients with androgen independent prostate cancer as measured by prostate specific antigen PSA-based response rate time to progression and overall survival II Identify the most promising regimen to use in a phase III trial based on toxic effects PSA-based response rates and clinical benefit
OUTLINE This is a randomized multicenter study Patients are stratified according to risk group low volume disease no more than 2 lesions on bone scan intermediate volume more than 2 bone lesions confined to axial skeleton or high volume bone lesions in appendicular skeletal or visceral lesions Patients are randomized to one of two treatment arms Arm I Patients receive oral estramustine three times a day and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2 Treatment repeats every 21 days Arm II Patients receive doxorubicin IV on days 1 15 and 29 vinblastine IV on days 8 22 and 36 oral ketoconazole three times a day on days 1-7 15-21 and 29-35 and oral estramustine three times a day on days 8-14 22-28 and 36-42 This regimen consists of 6 weeks of alternating chemotherapy and 2 weeks rest for an 8 week course Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 92 patients 46 per treatment arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to risk group low volume disease no more than 2 lesions on bone scan intermediate volume more than 2 bone lesions confined to axial skeleton or high volume bone lesions in appendicular skeletal or visceral lesions Patients are randomized to one of two treatment arms Arm I Patients receive oral estramustine three times a day and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2 Treatment repeats every 21 days Arm II Patients receive doxorubicin IV on days 1 15 and 29 vinblastine IV on days 8 22 and 36 oral ketoconazole three times a day on days 1-7 15-21 and 29-35 and oral estramustine three times a day on days 8-14 22-28 and 36-42 This regimen consists of 6 weeks of alternating chemotherapy and 2 weeks rest for an 8 week course Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 92 patients 46 per treatment arm 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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-DM-97022 | OTHER | None | None |
| NCI-T97-0023 | None | None | None |
| CDR0000065783 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |