Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003584
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Prednisone in Treating Patients With Recurrent andor Metastatic Kidney Cancer
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent Advanced and Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-05
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 Prednisone may help to relieve symptoms in patients with recurrent andor metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of vinorelbine and estramustine with or without prednisone in treating patients who have recurrent andor metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of vinorelbine and estramustine with or without prednisone in treating patients who have recurrent andor metastatic kidney cancer
Detailed Description:
OBJECTIVES I Estimate the response rate of vinorelbine and estramustine in patients with metastatic andor recurrent renal cell carcinoma II Obtain pilot data exploring the value of anti-inflammatory treatment in the management of severe systemic symptoms and improvement of treatment tolerance in this patient population
OUTLINE Patients are stratified according to number of risk factors 01 versus 2 versus 3 Patients receive vinorelbine IV on days 1 8 15 22 28 and 35 Patients also receive estramustine orally twice per day on days 1-7 and an increased dose on days 8-42 A tapered dose of oral prednisone is given to patients with an elevated erythrocyte sedimentation rate A course of treatment consists of 6 weeks of treatment followed by 2 weeks of rest Patients with stable disease may receive up to 4 courses of treatment Patients who achieve a partial response may undergo surgical resection followed by up to 2 additional courses of treatment or an interleukin-2 treatment regimen Patients with a complete response receive 1 additional course of treatment Patients are followed until death
PROJECTED ACCRUAL A maximum of 35 patients will be accrued for this study
OUTLINE Patients are stratified according to number of risk factors 01 versus 2 versus 3 Patients receive vinorelbine IV on days 1 8 15 22 28 and 35 Patients also receive estramustine orally twice per day on days 1-7 and an increased dose on days 8-42 A tapered dose of oral prednisone is given to patients with an elevated erythrocyte sedimentation rate A course of treatment consists of 6 weeks of treatment followed by 2 weeks of rest Patients with stable disease may receive up to 4 courses of treatment Patients who achieve a partial response may undergo surgical resection followed by up to 2 additional courses of treatment or an interleukin-2 treatment regimen Patients with a complete response receive 1 additional course of treatment Patients are followed until death
PROJECTED ACCRUAL A maximum of 35 patients 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 |
|---|---|---|---|
| NCI-V98-1477 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066653 | REGISTRY | None | None |