Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004105
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase III Study of Paclitaxel Estramustine Phosphate and Vinorelbine PaclEVin
Status:
COMPLETED
Status Verified Date:
2011-03
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of vinorelbine paclitaxel and estramustine in treating patients who have advanced cancer that has not responded to previous treatment
PURPOSE Phase III trial to study the effectiveness of vinorelbine paclitaxel and estramustine in treating patients who have advanced cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Establish the maximum tolerated doses MTDs and recommended Phase II doses RPTDs of vinorelbine and paclitaxel when combined with a fixed dose of estramustine in patients with advanced cancers or metastatic prostate cancer II Determine the toxicity pattern of this regimen at the MTDs and at the RPTDs in these patients III Make preliminary observations of antitumor activity in these patients treated with this regimen as leads for the Phase II portion of this study IV Establish the efficacy of the RPTDs of vinorelbine and paclitaxel when combined with estramustine in patients with prostate cancer who fulfill the criteria for the Phase II portion of this study
OUTLINE This is a dose escalation multicenter study of vinorelbine and paclitaxel Patients receive oral estramustine every 8 hours on days 0-2 and 7-9 and vinorelbine IV over 6-10 minutes immediately followed by paclitaxel IV over 1 hour on days 2 and 9 Courses repeat every 21 days Patients with complete response partial response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of vinorelbine and paclitaxel until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the lowest dose at which 2 or more of 3-6 patients experience dose limiting toxicity The recommended Phase II dose of vinorelbine or paclitaxel is defined as the dose immediately preceding the MTD
PROJECTED ACCRUAL A minimum of 12-16 patients will be accrued over 1 year for Phase I of the study and a total of 14-25 patients will be accrued for Phase II of the study
OUTLINE This is a dose escalation multicenter study of vinorelbine and paclitaxel Patients receive oral estramustine every 8 hours on days 0-2 and 7-9 and vinorelbine IV over 6-10 minutes immediately followed by paclitaxel IV over 1 hour on days 2 and 9 Courses repeat every 21 days Patients with complete response partial response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of vinorelbine and paclitaxel until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the lowest dose at which 2 or more of 3-6 patients experience dose limiting toxicity The recommended Phase II dose of vinorelbine or paclitaxel is defined as the dose immediately preceding the MTD
PROJECTED ACCRUAL A minimum of 12-16 patients will be accrued over 1 year for Phase I of the study and a total of 14-25 patients will be accrued for Phase II of the 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 |
|---|---|---|---|
| NCI-G99-1596 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9712 | None | None | None |