Back to resultsHepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer
Primary Purpose
Colon Cancer, Rectal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Floxuridine, Oxaliplatin, CPT-11
Floxuridine, Oxaliplatin, CPT-11
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring DEXAMETHASONE, FLOXURIDINE, IRINOTECAN (CPT-11) CAMPTOSAR, OXALIPLATIN
Eligibility Criteria
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.
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To determine the preliminary anti-tumor activity of the aforementioned combination chemotherapy.
To procure normal and disease liver tissue for evaluation of TS, p53, p21, TOPO 1, DPD, and ERCC levels.
Full Information
NCT ID
NCT00695201
First Posted
June 9, 2008
Last Updated
June 29, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Medicine and Dentistry of New Jersey, Rutgers, The State University of New Jersey, Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00695201
Brief Title
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer
Official Title
A Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Medicine and Dentistry of New Jersey, Rutgers, The State University of New Jersey, Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer
Keywords
DEXAMETHASONE, FLOXURIDINE, IRINOTECAN (CPT-11) CAMPTOSAR, OXALIPLATIN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Floxuridine, Oxaliplatin, CPT-11
Intervention Description
For patients on the 4-week cycle: On the first day of each cycle, the pump will be filled with FUDR and dexamethasone. The pump will be emptied of drugs after 2 weeks (on day 15 of each cycle) and filled with heparin (which is used to prevent blood from clotting) and saline. Whether the pump contains drug or heparin and saline, it will need to be emptied and refilled about every two weeks. We will inject either the drugs or the saline and heparin into the pump through the skin using a needle and syringe. In summary, 2 weeks of drug in the pump is followed by 2 weeks without drug in the pump. The systemic chemotherapy (Oxaliplatin/CPT-11) will be administered on the same day as the pump is filled and emptied, ie. Day 1 and Day 15 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Floxuridine, Oxaliplatin, CPT-11
Intervention Description
For patients on the 5-week cycle: On the first day of each cycle, the pump will be filled with FUDR and dexamethasone. The pump will be emptied of drugs after 2 weeks (on day 15 of each cycle) and filled with heparin and saline. This is repeated on day 29 of each cycle). In summary, 2 weeks of drug in the pump are followed by 3 weeks without drug in the pump. The systemic chemotherapy (Oxaliplatin/CPT-11) will be administered on the same day that the pump is emptied and filled with heparin and saline, i.e. Day 15 and Day 29 of each cycle.
Primary Outcome Measure Information:
Title
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.
Time Frame
conclusion of the study
Secondary Outcome Measure Information:
Title
To determine the preliminary anti-tumor activity of the aforementioned combination chemotherapy.
Time Frame
conclusion of the study
Title
To procure normal and disease liver tissue for evaluation of TS, p53, p21, TOPO 1, DPD, and ERCC levels.
Time Frame
conclusion of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Kemeny, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer
We'll reach out to this number within 24 hrs