Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066625
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2003-08-06
Brief Title:
Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of Oxaliplatin Eloxatin in Combination With Bortezomib PS-341 Velcade in Patients With Advanced Malignancy
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effect on the body of combining oxaliplatin with bortezomib in treating patients who have metastatic or unresectable cancer Drugs used in chemotherapy such as oxaliplatin use different ways to stop cancer cells from dividing so they stop growing or die Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth Combining oxaliplatin with bortezomib may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of oxaliplatin and bortezomib in patients with advanced malignancy
II Determine the dose-limiting toxicity of this regimen in these patients III Determine the toxicity profile of this regimen in these patients IV Determine the antitumor activity of this regimen in these patients V Determine the pattern of neurotoxicity and its reversibility in patients responding to prolonged administration of this treatment regimen
VI Determine whether the pharmacokinetics and pharmacodynamics of oxaliplatin or bortezomib are altered by the administration of the other agent in these patients
OUTLINE This is a dose-escalation study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and bortezomib IV over 3-5 seconds on days 1 4 15 and 18 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and bortezomib until the maximum tolerated doses MTDs are determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for at least 3 months
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 4-15 months
I Determine the maximum tolerated dose and recommended phase II dose of oxaliplatin and bortezomib in patients with advanced malignancy
II Determine the dose-limiting toxicity of this regimen in these patients III Determine the toxicity profile of this regimen in these patients IV Determine the antitumor activity of this regimen in these patients V Determine the pattern of neurotoxicity and its reversibility in patients responding to prolonged administration of this treatment regimen
VI Determine whether the pharmacokinetics and pharmacodynamics of oxaliplatin or bortezomib are altered by the administration of the other agent in these patients
OUTLINE This is a dose-escalation study
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and bortezomib IV over 3-5 seconds on days 1 4 15 and 18 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and bortezomib until the maximum tolerated doses MTDs are determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for at least 3 months
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 4-15 months
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 |
|---|---|---|---|
| CDR0000316444 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62204 |
| NYU 02-12 | None | None | None |
| N01CM62204 | NIH | None | None |