NCT00059930CompletedPhase 1
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
A Phase I Study Of Hepatic Arterial Infusion With Floxuridine And Dexamethasone In Combination With Intravenous Oxaliplatin Plus 5-Fluorouracil And Leucovorin As Adjuvant Treatment After Resection Of Hepatic Metastases From Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 6 May 2003
- Start date
- Jan 2003
- Primary completion date
- 24 Mar 2025
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT00059930
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 38
- From Jan 2003 to the primary completion date, 24 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Subject Inclusion Criteria:
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Confirmation of diagnosis must be performed at MSKCC.
- Potentially completely resectable hepatic metastases without current evidence of other metastatic disease.
- Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to registration. (MRI of abdomen may be substituted for CT of abdomen.)
- Lab values within 14 days prior to registration:
- WBC ≥ 3.0 K/ul
- ANC \>1.5 K/ul
- Platelets ≥ 100 K/ul
- Total bilirubin ≤ 1.5 mg/dl.
- Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study.
- KPS ≥ 60%
- Signed informed consent.
- Subject Exclusion Criteria:
- Prior radiation to the liver. (Prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.)
- Active infection, ascites, hepatic encephalopathy
- Prior oxaliplatin or cisplatin or HAI FUDR
- Female patients who are pregnant or lactating
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.