Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005077
Status:
COMPLETED
Last Update Posted:
2010-01-06
First Post:
2000-04-06
Brief Title:
Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Phase I Study of Oxaliplatin in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction Summary Last Modified 042000
Status:
COMPLETED
Status Verified Date:
2010-01
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
PURPOSE Phase I trial to study the effectiveness of oxaliplatin in treating patients who have advanced cancer plus liver dysfunction
PURPOSE Phase I trial to study the effectiveness of oxaliplatin in treating patients who have advanced cancer plus liver dysfunction
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of oxaliplatin in patients with advanced malignancies and varying degrees of liver dysfunction II Determine the effects of hepatic dysfunction on the plasma pharmacokinetics and pharmacodynamics of oxaliplatin in these patients
OUTLINE This is a dose escalation multicenter study Patients are stratified according to liver function as defined by the following Group A Normal liver function - Bilirubin SGOT and alkaline phosphatase no greater than upper limit of normal ULN Group B Mild liver dysfunction - Bilirubin no greater than ULN SGOT greater than ULN to 25 times ULN andor alkaline phosphatase greater than ULN to 5 times ULN Group C Moderate liver function - Bilirubin greater than ULN to 30 mgdL andor SGOT greater than 25 times ULN andor alkaline phosphatase greater than 5 times normal Group D Severe liver dysfunction - Bilirubin greater than 31 mgdL and any SGOT or alkaline phosphatase Group E Patients who have received a liver transplant Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients in groups B C and D receive escalating doses of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose- limiting toxicity
PROJECTED ACCRUAL Approximately 72 patients will be accrued for this study within 15 years
OUTLINE This is a dose escalation multicenter study Patients are stratified according to liver function as defined by the following Group A Normal liver function - Bilirubin SGOT and alkaline phosphatase no greater than upper limit of normal ULN Group B Mild liver dysfunction - Bilirubin no greater than ULN SGOT greater than ULN to 25 times ULN andor alkaline phosphatase greater than ULN to 5 times ULN Group C Moderate liver function - Bilirubin greater than ULN to 30 mgdL andor SGOT greater than 25 times ULN andor alkaline phosphatase greater than 5 times normal Group D Severe liver dysfunction - Bilirubin greater than 31 mgdL and any SGOT or alkaline phosphatase Group E Patients who have received a liver transplant Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients in groups B C and D receive escalating doses of oxaliplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose- limiting toxicity
PROJECTED ACCRUAL Approximately 72 patients will be accrued for this study within 15 years
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 |
|---|---|---|---|
| U01CA062505 | NIH | None | None |
| R03CA080647 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHI-26 | None | None | None |
| CHNMC-IRB-99108 | None | None | None |
| NCI-00-C-0172 | None | None | None |
| NCI-NMOB-B00-033 | None | None | None |
| PCI-99105 | None | None | None |
| NCI-T99-0050 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA033572 |