Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030797
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2002-02-14
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer
PURPOSE Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of different schedules of irinotecan in combination with capecitabine as first-line therapy in terms of objective response rate in patients with advanced or metastatic colorectal cancer
Compare the time to treatment failure time to progression and overall survival of patients treated with these regimens
Compare the safety profile in terms of toxicity of these regimens in these patients
Determine the quality of life in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1 disease symptoms including pain weight loss loss of appetite malaise and fever of unknown origin yes vs no weight loss during the past 6 months more than 5 vs 5 or less and disease-free interval more than 6 months vs 6 months or less Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 1 hour on days 1 8 15 22 and 29 and oral capecitabine twice daily on days 1-14 and 22-35
Arm II Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral capecitabine as in arm I
Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of each course and at the first visit after treatment failure
Patients are followed every 12 weeks for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 28-74 patients 14-37 per treatment arm will be accrued for this study
Compare the efficacy of different schedules of irinotecan in combination with capecitabine as first-line therapy in terms of objective response rate in patients with advanced or metastatic colorectal cancer
Compare the time to treatment failure time to progression and overall survival of patients treated with these regimens
Compare the safety profile in terms of toxicity of these regimens in these patients
Determine the quality of life in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1 disease symptoms including pain weight loss loss of appetite malaise and fever of unknown origin yes vs no weight loss during the past 6 months more than 5 vs 5 or less and disease-free interval more than 6 months vs 6 months or less Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 1 hour on days 1 8 15 22 and 29 and oral capecitabine twice daily on days 1-14 and 22-35
Arm II Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral capecitabine as in arm I
Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of each course and at the first visit after treatment failure
Patients are followed every 12 weeks for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 28-74 patients 14-37 per treatment arm 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 |
|---|---|---|---|
| EU-20141 | None | None | None |