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NCT00059930 · ClinicalTrials.gov registry record · Phase 1
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00059930: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00059930 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00059930, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to find the highest dose that can be given safely to people who have had liver disease resected. This is a Phase I study. The goal of a phase I study is to find a safe dose range based on side effects. The drugs that will be given by vein are OXALIPLATIN ("Oxali") plus 5-FLUOROURACIL and LEUCOVORIN ("5FU" and "LV"). This is systemic chemotherapy, since it goes to the whole body. The drugs that will be placed in the pump are FLOXURIDINE (FUDR) and DEXAMETHASONE. (The dexamethasone is not an anti-tumor drug; it helps protect healthy liver tissue from possible side effects of the FUDR.) This is the regional chemotherapy, since it goes only to the liver. The researchers have studied these drugs and know the best doses of each when they are used in patients who have not had liver resections. We do not yet know how the drugs work with each other in patients with a liver resection. This study will tell us the best doses of each drug when they are given over the same period of time.
Interventions
- DRUG FOLFOX regimen
- DRUG dexamethasone
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG floxuridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2003-01 |
| Est. Completion | 2025-03-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059930
The ClinicalTrials.gov registry entry for NCT00059930 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which FOLFOX regimen is the first listed.
NCT00059930 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059930 about?
NCT00059930 is a clinical study titled "Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer". The purpose of this study is to find the highest dose that can be given safely to people who have had liver disease resected. This is a Phase I study. The goal of a phase I study is to find a safe dose range based on side effects. The drugs that will be given by vein are OXALIPLATIN ("Oxali") plus 5...
What is the current status of trial NCT00059930?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2003-01. Estimated completion is 2025-03-24.
What interventions are being tested in trial NCT00059930?
The interventions under investigation include: FOLFOX regimen (DRUG), dexamethasone (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), floxuridine (DRUG).
Who is sponsoring clinical trial NCT00059930?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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