Colorectal Cancer, Metastatic Cancer
Conditions
Keywords
liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer
Brief 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
DRUGFOLFOX regimen
DRUGdexamethasone
DRUGfloxuridine
DRUGfluorouracil
DRUGleucovorin calcium
DRUGoxaliplatin
PROCEDUREadjuvant therapy
PROCEDUREconventional surgery
Sponsors
National Cancer Institute (NCI)
University of Medicine and Dentistry of New Jersey
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | 2 years |
| Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue | 2 years |
Countries
United States
Outcome results
None listed