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NCT00645710 · ClinicalTrials.gov registry record · Phase 1
Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery
A Phase 1 study of Liver Metastases and Recurrent Colon Cancer, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00645710 is a Phase 1 study of Liver Metastases and Recurrent Colon Cancer that has completed, run by City of Hope Medical Center. The registered enrollment target is 16 participants, below the 67-participant average among 27 other Liver Metastases trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00645710, a Phase 1 study of Liver Metastases and Recurrent Colon Cancer, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy and to see how well it works in treating liver metastases in patients with metastatic colorectal cancer.
Conditions Studied
Interventions
- DRUG floxuridine
- DRUG gemcitabine hydrochloride
- OTHER liquid chromatography
- GENETIC proteomic profiling
- OTHER matrix-assisted laser desorption/ionization time of flight mass spectrometry
Study Locations (1)
California
- City of Hope - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2005-02-11 |
| Est. Completion | 2018-02-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00645710
The ClinicalTrials.gov registry entry for NCT00645710 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 67-participant average among 27 other Liver Metastases trials with a reported enrollment target (76% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Liver Metastases appearing as the primary indexed condition, and to 5 interventions - of which floxuridine is the first listed.
NCT00645710 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00645710 about?
NCT00645710 is a clinical study titled "Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery". RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly int...
What is the current status of trial NCT00645710?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2005-02-11. Estimated completion is 2018-02-07.
What conditions does trial NCT00645710 study?
This clinical trial studies the following conditions: Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer.
What interventions are being tested in trial NCT00645710?
The interventions under investigation include: floxuridine (DRUG), gemcitabine hydrochloride (DRUG), liquid chromatography (OTHER), proteomic profiling (GENETIC), matrix-assisted laser desorption/ionization time of flight mass spectrometry (OTHER).
Who is sponsoring clinical trial NCT00645710?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00645710 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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