Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003394
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Study of Weekly Intravenous Estramustine Phosphate in Combination With Paclitaxel and Carboplatin in Patients With Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 III trial to study the effectiveness of combination chemotherapy consisting of estramustine paclitaxel and carboplatin in treating patients with advanced prostate cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy consisting of estramustine paclitaxel and carboplatin in treating patients with advanced prostate cancer
Detailed Description:
OBJECTIVES I Determine a safe weekly dose of intravenous estramustine EM in combination with paclitaxel TAX and carboplatin CBDCA in patients with advanced prostate cancer II Determine the safety and efficacy of this combination in androgen dependent vs androgen independent disease in these patients III Evaluate the pharmacokinetics of weekly intravenous EM and TAX in combination with CBDCA in these patients
OUTLINE Phase I is a dose escalation study of estramustine Phase II is a two stage design study in which patients are stratified according to androgen dependence androgen dependent disease vs androgen independent disease In phase I patients receive estramustine IV over 1 hour via permanent venous access device on day 1 of weeks 1 2 3 and 4 followed by paclitaxel TAX IV over 1 hour Carboplatin IV is administered over 30 minutes at the completion of TAX at week 1 Courses repeat every 4 weeks until disease progression or excessive toxicity or for up to 24 weeks Patients with locally advanced androgen dependent prostate cancer may be considered for radical prostatectomy or radiotherapy after 4 courses Androgen dependent patients not already on primary hormone therapy with a GnRH analog receive goserelin or leuprolide injections under the skin every 3 months while on the study beginning during the first or second week of therapy Three patients are entered at each dose level and must complete one course of therapy If no patient experiences dose limiting toxicity DLT then 3 patients are treated at the next higher dose level If 1 patient experiences DLT then 3 more patients are treated at that same dose level If 2 of 6 patients experience DLT then that dose is declared the maximum tolerated dose MTD In phase II a two stage design is applied to each patient population Fourteen patients are enrolled in the first stage If no responses are observed the trial is stopped If at least 1 response is observed 11 additional patients will be enrolled onto the study
PROJECTED ACCRUAL A total of 6-18 patients will be accrued to phase I phase II will accrue up to 50 patients within 3 years
OUTLINE Phase I is a dose escalation study of estramustine Phase II is a two stage design study in which patients are stratified according to androgen dependence androgen dependent disease vs androgen independent disease In phase I patients receive estramustine IV over 1 hour via permanent venous access device on day 1 of weeks 1 2 3 and 4 followed by paclitaxel TAX IV over 1 hour Carboplatin IV is administered over 30 minutes at the completion of TAX at week 1 Courses repeat every 4 weeks until disease progression or excessive toxicity or for up to 24 weeks Patients with locally advanced androgen dependent prostate cancer may be considered for radical prostatectomy or radiotherapy after 4 courses Androgen dependent patients not already on primary hormone therapy with a GnRH analog receive goserelin or leuprolide injections under the skin every 3 months while on the study beginning during the first or second week of therapy Three patients are entered at each dose level and must complete one course of therapy If no patient experiences dose limiting toxicity DLT then 3 patients are treated at the next higher dose level If 1 patient experiences DLT then 3 more patients are treated at that same dose level If 2 of 6 patients experience DLT then that dose is declared the maximum tolerated dose MTD In phase II a two stage design is applied to each patient population Fourteen patients are enrolled in the first stage If no responses are observed the trial is stopped If at least 1 response is observed 11 additional patients will be enrolled onto the study
PROJECTED ACCRUAL A total of 6-18 patients will be accrued to phase I phase II will accrue up to 50 patients within 3 years
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 |
|---|---|---|---|
| CDR0000066392 | REGISTRY | None | None |
| NCI-G98-1448 | Registry Identifier | PDQ Physician Data Query | None |