Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/7/2018 |
| Start Date: | January 2003 |
| End Date: | June 2019 |
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
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.
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.
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
We found this trial at
2
sites
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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195 Little Albany St
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
(732) 235-2465
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
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