Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004252
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
2000-01-28
Brief Title:
Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Open-Label Multicenter Phase III Study of 5-FULeucovorin With or Without Concomitant SU5416 in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor It is not yet known whether chemotherapy is more effective with or without SU5416 in treating metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of leucovorin and fluorouracil with or without SU5416 in treating patients who have metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of leucovorin and fluorouracil with or without SU5416 in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Compare the median survival in patients with metastatic colorectal cancer treated with fluorouracil and leucovorin calcium with or without SU5416 II Compare the time to progression duration of response and objective response in these patients on these two regimens III Compare the percentage 6 month 9 month and one year survival of these patients on these two regimens IV Compare the time to treatment failure in these patients on these two regimens V Determine the health related quality of life of these patients on these two regimens VI Compare the palliative and biologic effects of SU5416 in these patients VII Determine the safety and tolerability of fluorouracil and leucovorin calcium plus SU5416 in these patients
OUTLINE This is a randomized open label multicenter study Patients are stratified according to performance status ECOG 0 vs 1 site of primary disease colon vs rectum measurable or evaluable disease and prior fluorouracil adjuvant chemotherapy none vs at least 1 dose Patients are randomized to one of two treatment arms Arm I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6 weeks Arm II Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6 weeks plus SU5416 twice weekly for 8 weeks Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to study at weeks 4 and 8 of each course and then post study Patients are followed post study at one month and then every 2 months until death
PROJECTED ACCRUAL A total of 710 patients 355 per treatment arm will be accrued for this study
OUTLINE This is a randomized open label multicenter study Patients are stratified according to performance status ECOG 0 vs 1 site of primary disease colon vs rectum measurable or evaluable disease and prior fluorouracil adjuvant chemotherapy none vs at least 1 dose Patients are randomized to one of two treatment arms Arm I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6 weeks Arm II Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6 weeks plus SU5416 twice weekly for 8 weeks Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed prior to study at weeks 4 and 8 of each course and then post study Patients are followed post study at one month and then every 2 months until death
PROJECTED ACCRUAL A total of 710 patients 355 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 |
|---|---|---|---|
| UCLA-9909008 | None | None | None |
| CDR0000067499 | None | None | None |