Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001835
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Oxaliplatin in Cancer Patients With Impaired Kidney Function
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Oxaliplatin in Adult Cancer Patients With Impaired Renal Function
Status:
COMPLETED
Status Verified Date:
2001-12
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:
Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer However because this drug can damage the kidneys it is necessary to determine what doses of the drug can safely be given to patients with poor kidney function
Patients with advanced cancer poorly functioning kidneys and no good standard treatment options are eligible for this study Candidates will be screened with imaging tests such as CT and MRI scans to determine the size and location of the cancer and with blood and urine tests to evaluate kidney and liver function
Study participants will receive oxaliplatin intravenously through a vein every 3 weeks for as long as the cancer is under control and there are no serious side effects from the drug If significant side effects develop the dosage will be reduced or the drug will be stopped Blood tests to measure blood cell counts will be done at least once a week and CT scans chest X-rays and MRIs will be done about once every 6 weeks to assess the tumors response to the treatment Additional blood tests will be done at the beginning of the first two treatment cycles to measure the amount of oxaliplatin in the blood and urine will be collected during the first 24 hours of drug treatment to determine how much drug is eliminated by the body in urine
Patients with advanced cancer poorly functioning kidneys and no good standard treatment options are eligible for this study Candidates will be screened with imaging tests such as CT and MRI scans to determine the size and location of the cancer and with blood and urine tests to evaluate kidney and liver function
Study participants will receive oxaliplatin intravenously through a vein every 3 weeks for as long as the cancer is under control and there are no serious side effects from the drug If significant side effects develop the dosage will be reduced or the drug will be stopped Blood tests to measure blood cell counts will be done at least once a week and CT scans chest X-rays and MRIs will be done about once every 6 weeks to assess the tumors response to the treatment Additional blood tests will be done at the beginning of the first two treatment cycles to measure the amount of oxaliplatin in the blood and urine will be collected during the first 24 hours of drug treatment to determine how much drug is eliminated by the body in urine
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 with normal renal function is 130 mgm2 given intravenously over 2 hours every 3 weeks Renal excretion is thought to be the major route of drug elimination but precise dosing guidelines in patients with abnormal renal function have not been determined This phase I and pharmacologic study of single agent Oxaliplatin is being conducted in adult cancer patients with impaired renal function Patients will be stratified into four groups based upon their degree of renal impairment as assessed by a 24 hour creatinine clearance Group A will consist of 12 patients with normal renal function who will serve as pharmacologic controls The remaining 3 groups will start at different doses of Oxaliplatin based upon their degree of renal dysfunction and dose escalation in these groups will proceed in a manner in accordance with standard phase I trials 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 patient with different degrees of renal dysfunction
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 |
|---|---|---|---|
| 99-C-0171 | None | None | None |