Oxaliplatin in Cancer Patients With Impaired Kidney Function
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|ClinicalTrials.gov Identifier: NCT00001835|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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 tumor's 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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Disease Neoplasm Neoplasm Metastasis||Drug: Oxaliplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Official Title:||A Phase I Study of Oxaliplatin in Adult Cancer Patients With Impaired Renal Function|
|Study Start Date :||September 1999|
|Study Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001835
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|