Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166465
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
2005-09-12
Brief Title:
Stage IV Colorectal CA ALIMTA
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase I Dose-Finding Study and a Randomized Phase II Study of ALIMTA Plus Oxaliplatin Versus Oxaliplatin Plus 5-Fluorouracil and Leucovorin FOLFOX 4 Regimen in the First-Line Treatment of Patients With Locally Advanced Unresectable or Stage IV Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2011-03
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:
Phase I The primary objective of the Phase 1 portion of this study is to determine the Maximum tolerated dose and the recommended Phase 2 dose of ALIMTA plus oxaliplatin when given with folate and vitamin B-12 supplementation in the treatment of patients with unresectable locally advanced or metastatic colorectal cancer The Phase I component of the study will be activated for enrollment of Mayo Clinic patients only
Phase II The primary objective of the Phase 2 portion of this study is to determine the tumor response rates to ALIMTA plus oxaliplatin and oxaliplatin plus 5-fluorouracil and leucovorin in patients with locally advanced unresectable or Stage IV colorectal cancer that have not received prior chemotherapy for advanced disease Patients will be randomly assigned to receive either ALIMTA plus oxaliplatin Arm A or Oxaliplatin plus 5-Fluorouracil and Leucovorin Arm B The Phase II component of the study will be activated for enrollment of patients via the Mayo Clinic Cancer Research Consortium mechanism A comparison will be made of the side effects between regimens
Phase II The primary objective of the Phase 2 portion of this study is to determine the tumor response rates to ALIMTA plus oxaliplatin and oxaliplatin plus 5-fluorouracil and leucovorin in patients with locally advanced unresectable or Stage IV colorectal cancer that have not received prior chemotherapy for advanced disease Patients will be randomly assigned to receive either ALIMTA plus oxaliplatin Arm A or Oxaliplatin plus 5-Fluorouracil and Leucovorin Arm B The Phase II component of the study will be activated for enrollment of patients via the Mayo Clinic Cancer Research Consortium mechanism A comparison will be made of the side effects between regimens
Detailed Description:
ALIMTA oxaliplatin and 5-fluorouracil alone or with leucovorin have shown activity as single agents in the treatment of colorectal cancer Their different mechanisms of action make the combination of ALIMTA with oxaliplatin attractive as potential first-line therapies in terms of improving response rates and overall survival in patients with metastatic colorectal cancer Current reports of the combination of oxaliplatin and 5-FU as first-line therapies suggest that there may be advantages in combining oxaliplatin with other antifolates in the treatment of colorectal cancer ALIMTA is an attractive candidate to replace other drugs such as 5-FU in the combinations with oxaliplatin in the treatment of locally advanced and metastatic colorectal cancer ALIMTA has potential advantages over 5-FU when combined with oxaliplatin because it requires a single short injection and inhibits multiple targets in the folate pathway Therefore we propose to conduct a trial reporting the clinical effectiveness and side effects of ALIMTA plus oxaliplatin and one of the current standards of care the FOLFOX 4 regimen Oxaliplatin plus 5-Fluorouracil and Leucovorin
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 |
|---|---|---|---|
| 1126-03 | OTHER | Mayo Clinic IRB | None |
| MC0248 | OTHER | None | None |