Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098982
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
2004-12-08
Brief Title:
Bortezomib Fluorouracil Leucovorin and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I Study of PS-341 VELCADE in Combination With 5FULV Plus Oxaliplatin in Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 such as fluorouracil leucovorin and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It may also help the chemotherapy drugs work better by making tumor cells more sensitive to the drugs Giving bortezomib with fluorouracil leucovorin and oxaliplatin may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib when given with fluorouracil leucovorin and oxaliplatin in treating patients with advanced or metastatic colorectal cancer
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib when given with fluorouracil leucovorin and oxaliplatin in treating patients with advanced or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of bortezomib when administered with fluorouracil leucovorin calcium and oxaliplatin in patients with advanced or metastatic colorectal cancer
Determine the recommended phase II dose of bortezomib in patients treated with this regimen
Secondary
Determine response in patients with measurable disease treated with this regimen
OUTLINE This is an open-label non-randomized multicenter dose-escalation study of bortezomib
Patients receive bortezomib IV over 3-5 seconds on days 1 8 and 15 oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 2 15 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients receive treatment at the MTD to a maximum of 12 patients at that dose level
Patients are followed every 8 weeks until disease progression or start of a new anticancer treatment
PROJECTED ACCRUAL Not specified
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of bortezomib when administered with fluorouracil leucovorin calcium and oxaliplatin in patients with advanced or metastatic colorectal cancer
Determine the recommended phase II dose of bortezomib in patients treated with this regimen
Secondary
Determine response in patients with measurable disease treated with this regimen
OUTLINE This is an open-label non-randomized multicenter dose-escalation study of bortezomib
Patients receive bortezomib IV over 3-5 seconds on days 1 8 and 15 oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 2 15 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients receive treatment at the MTD to a maximum of 12 patients at that dose level
Patients are followed every 8 weeks until disease progression or start of a new anticancer treatment
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| 2004-001763-21 | EUDRACT_NUMBER | None | None |
| EORTC-16029 | None | None | None |
| MILLENNIUM-EORTC-16029 | None | None | None |