Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049335
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2002-11-12
Brief Title:
S0030 Capecitabine in Treating Older Patients WMetastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older And In A Cohort Of Patients Younger Than 60 Years
Status:
COMPLETED
Status Verified Date:
2013-01
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
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES
Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study
Determine the anticancer efficacy of capecitabine in terms of objective response rate confirmed and unconfirmed complete and partial responses and 2-year survival in these patients
Determine the toxicity and tolerability of this drug in these patients
Determine the feasibility of using standardized self-report measures of comorbidity depression and functional status of patients treated with this drug
Determine the clinical pharmacology of this drug in these patients
Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature
OUTLINE This is a multicenter study Patients are stratified according to age 70 and over vs 18 to 59
Patients receive oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 80 patients 60 patients aged 70 and over 20 patients aged 18 to 59 will be accrued for this study
Determine the feasibility of enrolling patients aged 70 and over with unresectable metastatic or recurrent colorectal cancer to a structured phase II study
Determine the anticancer efficacy of capecitabine in terms of objective response rate confirmed and unconfirmed complete and partial responses and 2-year survival in these patients
Determine the toxicity and tolerability of this drug in these patients
Determine the feasibility of using standardized self-report measures of comorbidity depression and functional status of patients treated with this drug
Determine the clinical pharmacology of this drug in these patients
Determine whether patients under 60 years of age treated with this drug have clinical pharmacologic parameters similar to those reported in the literature
OUTLINE This is a multicenter study Patients are stratified according to age 70 and over vs 18 to 59
Patients receive oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 80 patients 60 patients aged 70 and over 20 patients aged 18 to 59 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0030 | OTHER | None | None |