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NCT00001835 · ClinicalTrials.gov registry record · Phase 1
Oxaliplatin in Cancer Patients With Impaired Kidney Function
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00001835: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001835 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001835, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG Oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 1999-09 |
| Est. Completion | 2001-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001835
The ClinicalTrials.gov registry entry for NCT00001835 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxaliplatin is the first listed.
NCT00001835 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001835 about?
NCT00001835 is a clinical study titled "Oxaliplatin in Cancer Patients With Impaired Kidney Function". 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 functi...
What is the current status of trial NCT00001835?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 1999-09. Estimated completion is 2001-12.
What interventions are being tested in trial NCT00001835?
The interventions under investigation include: Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00001835?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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