Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006062
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-07-11
Brief Title:
Oxaliplatin to Treat Advanced Cancers With Liver Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of Oxaliplatin in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction
Status:
COMPLETED
Status Verified Date:
2000-06
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:
This is a phase I study of the experimental anticancer drug oxaliplatin It is designed to establish the maximum dose of the drug that can be given safely to patients with cancer who have impaired liver function and to determine the drugs side effects It will also examine how liver function affects the drugs elimination from the body The liver plays an important role in the elimination of many anticancer drugs and patients with impaired liver function should not take certain drugs or should take them in reduced doses
Patients 18 years of age and older with cancer that has metastasized spread from the original tumor site and for whom standard treatment is not available or is no longer effective may be eligible for this study Candidates will be screened with various tests and procedures that may include physical examination computerized tomography CT or magnetic resonance imaging MRI scans chest X-rays and blood and urine tests
Participants will be given oxaliplatin in doses determined according to their level of liver function Patients may have normal liver function or mildly moderately or severely impaired liver function or may have had a liver transplant Oxaliplatin will be infused intravenously through a vein over two hours on the first day of 21-day treatment cycles-that is once every 3 weeks Treatment will continue as long as the cancer is under control and side effects do not require stopping the drug Urine will be collected over 48 hours after the infusion to determine how much of the drug is eliminated in urine Blood tests will be done to monitor safety of the treatment and imaging studies such as X-rays CT and MRI scans will be done periodically to evaluate the tumors response to treatment
Special blood tests will also be done to study how oxaliplatin is eliminated from the body With the first dose of the drug blood samples will be collected just before the infusion begins just before it ends 15 minutes 30 minutes 1 2 4 6 24 48 and 72 hours after the infusion and again 1 week and 3 weeks later Additional blood samples may be collected at the third treatment cycle
Patients 18 years of age and older with cancer that has metastasized spread from the original tumor site and for whom standard treatment is not available or is no longer effective may be eligible for this study Candidates will be screened with various tests and procedures that may include physical examination computerized tomography CT or magnetic resonance imaging MRI scans chest X-rays and blood and urine tests
Participants will be given oxaliplatin in doses determined according to their level of liver function Patients may have normal liver function or mildly moderately or severely impaired liver function or may have had a liver transplant Oxaliplatin will be infused intravenously through a vein over two hours on the first day of 21-day treatment cycles-that is once every 3 weeks Treatment will continue as long as the cancer is under control and side effects do not require stopping the drug Urine will be collected over 48 hours after the infusion to determine how much of the drug is eliminated in urine Blood tests will be done to monitor safety of the treatment and imaging studies such as X-rays CT and MRI scans will be done periodically to evaluate the tumors response to treatment
Special blood tests will also be done to study how oxaliplatin is eliminated from the body With the first dose of the drug blood samples will be collected just before the infusion begins just before it ends 15 minutes 30 minutes 1 2 4 6 24 48 and 72 hours after the infusion and again 1 week and 3 weeks later Additional blood samples may be collected at the third treatment cycle
Detailed Description:
Oxaliplatin is a diaminocyclohexane platinum derivative with known anticancer activity in solid tumors The recommended single-agent dose of oxaliplatin in adult cancer patients is 130 mgm2 given intravenously over 2 hours every 3 weeks Hepatic metabolism is the major route of drug elimination for many anti-cancer agents Although there is limited safety and pharmacokinetic data for oxaliplatin in patients with renal impairment there is currently no data regarding its disposition in patients with liver dysfunction This phase I and pharmacologic study of a single agent oxaliplatin is being conducted in adult cancer patients with advanced malignancies and varying degrees of liver dysfunction Patients will be stratified into five groups based upon their degree of liver dysfunction as assessed by liver function tests Group A will consist of patients with normal hepatic function to serve as pharmacologic controls Group E will consist of patients who have received a liver transplant The remaining 3 groups will start at different doses of oxaliplatin based on hepatic dysfunction and dose escalation in these groups will proceed in a manner in accordance with standard phase I trial with 3 patients per dose level until dose limiting toxicity is observed Pharmacokinetic monitoring will be performed in all patients on study The goals of this trial are to define the toxicities and pharmacokinetics of single agent oxaliplatin in this patient population and to determine recommended doses of oxaliplatin in patients with different degrees of hepatic impairment
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 |
|---|---|---|---|
| 00-C-0172 | None | None | None |