Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021281
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized Open-Label Multicenter International Study Comparing The Combination Of SU5416Irinotecan5-FluorouracilLeucovorin Versus IrinotecanFluorouracilLeucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2001-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 SU5416 may stop the growth of tumor cells by stopping blood flow to the tumor It is not yet known whether combination chemotherapy will be more effective with or without SU5416 in treating metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without SU5416 in treating patients who have metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without SU5416 in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Compare the survival of patients with previously untreated metastatic colorectal cancer treated with fluorouracil leucovorin calcium and irinotecan with or without SU5416 II Compare the antitumor efficacy of these regimens in these patients III Evaluate the additional measures of clinical benefit in patients treated with these regimens IV Determine the relative safety profile of these regimens in these patients V Assess quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to ECOG performance status 0 vs 1 baseline lactate dehydrogenase normal vs elevated and treatment regimen Patients are randomized to 1 of 2 treatment arms by 2 different regimens Saltz vs de Gramont Regimen I Saltz Arm IA Patients receive SU5416 IV over 1 hour on days 1 4 8 11 15 18 22 25 29 32 36 and 39 Patients also receive irinotecan IV over 30-90 minutes leucovorin calcium IV over 5-10 minutes and fluorouracil IV over 5-10 minutes on days 1 8 15 and 22 Arm IIA Patients receive irinotecan leucovorin calcium and fluorouracil as in arm I Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Regimen II de Gramont Arm IB Patients receive SU5416 as in arm IA Patients also receive irinotecan IV over 30-90 minutes on days 1 15 and 29 and leucovorin calcium IV over 2 hours and fluorouracil IV over 2 hours on days 1 2 15 16 29 and 30 Arm IIB Patients receive irinotecan leucovorin calcium and fluorouracil as in arm IB Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the beginning of each course and then at the end of treatment Patients are followed at 1 month and then every 2 months for 4 years
PROJECTED ACCRUAL A total of 1270 patients 635 per treatment arm will be accrued for this study within 2 years
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to ECOG performance status 0 vs 1 baseline lactate dehydrogenase normal vs elevated and treatment regimen Patients are randomized to 1 of 2 treatment arms by 2 different regimens Saltz vs de Gramont Regimen I Saltz Arm IA Patients receive SU5416 IV over 1 hour on days 1 4 8 11 15 18 22 25 29 32 36 and 39 Patients also receive irinotecan IV over 30-90 minutes leucovorin calcium IV over 5-10 minutes and fluorouracil IV over 5-10 minutes on days 1 8 15 and 22 Arm IIA Patients receive irinotecan leucovorin calcium and fluorouracil as in arm I Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Regimen II de Gramont Arm IB Patients receive SU5416 as in arm IA Patients also receive irinotecan IV over 30-90 minutes on days 1 15 and 29 and leucovorin calcium IV over 2 hours and fluorouracil IV over 2 hours on days 1 2 15 16 29 and 30 Arm IIB Patients receive irinotecan leucovorin calcium and fluorouracil as in arm IB Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline at the beginning of each course and then at the end of treatment Patients are followed at 1 month and then every 2 months for 4 years
PROJECTED ACCRUAL A total of 1270 patients 635 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| NCI-G01-1980 | None | None | None |
| UCLA-001003701 | None | None | None |
| SUGEN-SU5416035 | None | None | None |