Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005036
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2000-04-06
Brief Title:
Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Equivalence Trial of Irinotecan CPT-11 Versus Oxaliplatin OXAL5-Fluorouracil 5-FULeucovorin CF in Patients With Advanced Colorectal Carcinoma Previously Treated With 5-FU
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment 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 It is not yet known which chemotherapy regimen is more effective for colorectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine whether in advanced colorectal carcinoma patients who have been previously treated with 5-FU the overall survival of patients treated with OXAL 5-FU CF followed by CPT-11 is equivalent to the survival of patients treated with CPT-11 followed by OXAL 5-FU CF
SECONDARY OBJECTIVES
I Evaluation of time to tumor progression time to treatment failure toxicity of treatment and overall response rate in patients treated with these two regimens
II To compare quality-of-life measurements patients treated with these two regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status ECOG 0-1 vs 2 primary indicator lesion hepatic vs pulmonary vs other age less than 65 vs at least 65 years alkaline phosphatase less than 2 vs at least 2 times ULN fluorouracil failure adjuvant vs metastatic and membership intergroup vs expanded participation project Patients are randomized to one of two treatment arms
ARM I Patients receive irinotecan IV over 90 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
ARM II Patients receive oxaliplatin IV over 2 hours on day 1 leucovorin calcium IV over 2 hours on days 1 and 2 and fluorouracil IV bolus followed by IV infusion over 22 hours on days 1 and 2 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity
Patients who experience progression or toxicity on the initial regimen may crossover to the other regimen At least 3 weeks must elapse between regimens
Quality of life is assessed at baseline prior to each chemotherapy course at crossover and at the end of the study
Patients are followed every 6 months for 3 years or until death
I Determine whether in advanced colorectal carcinoma patients who have been previously treated with 5-FU the overall survival of patients treated with OXAL 5-FU CF followed by CPT-11 is equivalent to the survival of patients treated with CPT-11 followed by OXAL 5-FU CF
SECONDARY OBJECTIVES
I Evaluation of time to tumor progression time to treatment failure toxicity of treatment and overall response rate in patients treated with these two regimens
II To compare quality-of-life measurements patients treated with these two regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status ECOG 0-1 vs 2 primary indicator lesion hepatic vs pulmonary vs other age less than 65 vs at least 65 years alkaline phosphatase less than 2 vs at least 2 times ULN fluorouracil failure adjuvant vs metastatic and membership intergroup vs expanded participation project Patients are randomized to one of two treatment arms
ARM I Patients receive irinotecan IV over 90 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
ARM II Patients receive oxaliplatin IV over 2 hours on day 1 leucovorin calcium IV over 2 hours on days 1 and 2 and fluorouracil IV bolus followed by IV infusion over 22 hours on days 1 and 2 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity
Patients who experience progression or toxicity on the initial regimen may crossover to the other regimen At least 3 weeks must elapse between regimens
Quality of life is assessed at baseline prior to each chemotherapy course at crossover and at the end of the study
Patients are followed every 6 months for 3 years or until death
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 |
|---|---|---|---|
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |
| N9841 | None | None | None |
| SWOG-N9841 | None | None | None |
| NCCTG-N9841 | None | None | None |
| CDR0000067623 | None | None | None |
| ECOG-N9841 | None | None | None |