Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022633
Status:
TERMINATED
Last Update Posted:
2016-08-11
First Post:
2001-08-10
Brief Title:
S0028 Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older and in a Cohort of Patients Younger Than 60 Years
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Permanently Closed Due to Poor Accrual
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 Giving more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract
Detailed Description:
OBJECTIVES
Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study
Determine the anticancer efficacy of gemcitabine and paclitaxel in terms of objective response rate and 2-year survival in these elderly patients
Assess the toxicity and tolerability of this regimen in these elderly patients
Determine the feasibility of using standardized self-report measures of comorbidity depression and functional status in these patients
Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years
OUTLINE This is a multicenter study Patients are stratified according to age 70 and over vs under 60
Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 80 patients 60 age 70 and over and 20 under age 60 will be accrued for this study
Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study
Determine the anticancer efficacy of gemcitabine and paclitaxel in terms of objective response rate and 2-year survival in these elderly patients
Assess the toxicity and tolerability of this regimen in these elderly patients
Determine the feasibility of using standardized self-report measures of comorbidity depression and functional status in these patients
Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years
OUTLINE This is a multicenter study Patients are stratified according to age 70 and over vs under 60
Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 80 patients 60 age 70 and over and 20 under age 60 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 |
|---|---|---|---|
| S0028 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |