Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104689
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2005-03-03
Brief Title:
Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase II Trial Assessing the Impact on the Activity of Daily Living of an Oral Chemotherapy by Capecitabine Associated With an Intravenous Chemotherapy by Oxaliplatin as First Line Treatment of Metastatic Colorectal Adenocarcinoma of Patients Aged Over 70
Status:
COMPLETED
Status Verified Date:
2021-02
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 such as capecitabine and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer
PURPOSE This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of capecitabine and oxaliplatin as first-line treatment as defined by stabilization or improvement by 1 point on Katzs Activities of Daily Living scale in older patients with metastatic colorectal adenocarcinoma
Secondary
Determine the toxicity of this regimen in these patients
Determine the percentage of patients who receive the first 3 courses of this regimen at lower doses and the percentage of patients who receive all 6 courses of this regimen at both lower and higher doses
Determine efficacy of this regimen as defined by RECIST criteria in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter open-label nonrandomized study
Patients receive oral capecitabine once daily on days 1-14 and oxaliplatin IV on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary
Determine the efficacy of capecitabine and oxaliplatin as first-line treatment as defined by stabilization or improvement by 1 point on Katzs Activities of Daily Living scale in older patients with metastatic colorectal adenocarcinoma
Secondary
Determine the toxicity of this regimen in these patients
Determine the percentage of patients who receive the first 3 courses of this regimen at lower doses and the percentage of patients who receive all 6 courses of this regimen at both lower and higher doses
Determine efficacy of this regimen as defined by RECIST criteria in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter open-label nonrandomized study
Patients receive oral capecitabine once daily on days 1-14 and oxaliplatin IV on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20500 | None | None | None |
| FRE-FNCLCC-GERICO-020301 | None | None | None |