Status:
COMPLETED
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of Medicine and Dentistry of New Jersey
Rutgers, The State University of New Jersey
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see how well patients tolerate the side effects of treatment with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used together are a use...
Eligibility Criteria
Inclusion
- 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.
- Patient's liver metastases must be deemed unresectable and comprise \<70% of the liver parenchyma.
- A patient may have had prior chemotherapy or be previously untreated.
- Patient may not have received prior treatment with FUDR or \>2 doses of Oxaliplatin.
- KPS \> or = to 60%.
- WBC \> or = to 3,000 cells/mm3 and platelet count \> or = to 100,000 cells/mm3 within 14 days of registration.
- Creatinine \< or = to 1.5 mg/dl within 14 days of registration.
- Total serum bilirubin \< or = 2.0 mg/dl within 14 days of registration.
Exclusion
- No active concurrent malignancies: except a patient's potentially resectable colorectal primary.
- Patient must not have obstruction of GI or GU tract.
- Patient must not have current, symptomatic peripheral sensory neuropathy.
- No prior radiation to liver.
- No active infection, ascites, or hepatic encephalopathy.
- Age ≥ 18 years.
- Female patients cannot be pregnant or lactating.
- Signed informed consent.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00695201
Start Date
August 1 2000
End Date
June 28 2021
Last Update
July 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065