Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007878
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2001-01-06
Brief Title:
Bortezomib Fluorouracil and Leucovorin Calcium in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of PS-341 in Combination With 5-FULV in Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This phase I trial studies the side effects and best dose of bortezomib when given together with fluorouracil and leucovorin calcium in treating patients with solid tumors that are metastatic or cannot be removed by surgery Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as fluorouracil and leucovorin calcium work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bortezomib together with chemotherapy may be an effective treatment for solid tumors
Detailed Description:
PRIMARY OBJECTIVES
I To determine the dose limiting toxicity DLT and maximum tolerated dose MTD of PS-341 bortezomib when administered as a bolus injection two times a week on days 1 and 4 for 2 weeks followed by one week of rest
II To evaluate the pharmacodynamics of PS-341 by determining the 20S proteasome and nuclear factor kappa-light chain enhancer of activated B cells NFkB inhibition in blood of patients treated with intravenous PS-341 combined with weekly fluorouracil 5-FU and leucovorin calcium LV
SECONDARY OBJECTIVES
I To identify any objective tumor response in patients treated with intravenous PS-341
II To evaluate the relationship between inhibition of the 20S proteasome and NFkB and clinical toxicity
III To obtain preliminary data on molecular correlates of response to PS-341 and 5-FU and LV including genes involved in apoptosis cell cycle control transcriptional regulation and adhesionangiogenesis based on the mechanisms of PS-341 IV To examine the pharmacokinetics of 5-FU when co-administered with PS-341
OUTLINE This is a dose-escalation study of bortezomib
Patients receive bortezomib intravenously IV on days 1 and 4 and fluorouracil IV and leucovorin calcium IV on day 1 weekly for 2 weeks Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
I To determine the dose limiting toxicity DLT and maximum tolerated dose MTD of PS-341 bortezomib when administered as a bolus injection two times a week on days 1 and 4 for 2 weeks followed by one week of rest
II To evaluate the pharmacodynamics of PS-341 by determining the 20S proteasome and nuclear factor kappa-light chain enhancer of activated B cells NFkB inhibition in blood of patients treated with intravenous PS-341 combined with weekly fluorouracil 5-FU and leucovorin calcium LV
SECONDARY OBJECTIVES
I To identify any objective tumor response in patients treated with intravenous PS-341
II To evaluate the relationship between inhibition of the 20S proteasome and NFkB and clinical toxicity
III To obtain preliminary data on molecular correlates of response to PS-341 and 5-FU and LV including genes involved in apoptosis cell cycle control transcriptional regulation and adhesionangiogenesis based on the mechanisms of PS-341 IV To examine the pharmacokinetics of 5-FU when co-administered with PS-341
OUTLINE This is a dose-escalation study of bortezomib
Patients receive bortezomib intravenously IV on days 1 and 4 and fluorouracil IV and leucovorin calcium IV on day 1 weekly for 2 weeks Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
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-2012-03190 | REGISTRY | None | None |
| NCI-T99-0048 | None | None | None |
| LAC-USC-0C003 | None | None | None |
| CHNMC-PHI-27 | None | None | None |
| CDR0000068327 | None | None | None |
| PHI-27 USC 0C-00-03 | OTHER | None | None |
| T99-0048 | OTHER | None | None |
| U01CA062505 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062505 |