Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer

Phase 1

Completed

• Conditions: Colon Cancer; Rectal Cancer
• Interventions: Drug: Floxuridine, Oxaliplatin, CPT-11

• Registration Number: NCT00695201
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 useful way of treating cancer. We have studied these drugs and know the best doses of each when they are used alone. We do not yet know how well the drugs work with each other. This study will tell us the best doses of each drug when they are given over the same period of time.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-11
• Status Verified: 2021-06
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-28
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Floxuridine, Oxaliplatin, CPT-11	Patients will undergo pump placement and biopsy of diseased liver tissue. Chemotherapy will be initiated as soon as possible following verification of adequate pump placement and perfusion by radiographic pump study. Treatment will continue indefinitely unless a patient experiences a treatment endpoint.
2	Floxuridine, Oxaliplatin, CPT-11	Patients will undergo pump placement and biopsy of diseased liver tissue. Chemotherapy will be initiated as soon as possible following verification of adequate pump placement and perfusion by radiographic pump study. Treatment will continue indefinitely unless a patient experiences a treatment endpoint.

Primary Outcome Measures

Name	Time	Method
Determine the MTD of hepatic arterial floxuridine (FUDR) & dexamethasone (Dex) given via implanted pump in combination w biweekly intravenous Oxaliplatin + systemic irinotecan (CPT-11) in patients w unresectable hepatic metastases from colorectal cancer.	conclusion of the study

Secondary Outcome Measures

Name	Time	Method
To determine the preliminary anti-tumor activity of the aforementioned combination chemotherapy.	conclusion of the study
To procure normal and disease liver tissue for evaluation of TS, p53, p21, TOPO 1, DPD, and ERCC levels.	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States