- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00059930
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer
July 3, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy
This is a Phase I study with the primary objective of defining the maximum tolerated dose of hepatic arterial floxuridine (FUDR) and dexamethasone (Dex) given via an implanted pump in combination with intravenous oxaliplatin plus systemic fluorouracil (5FU)/leucovorin (LV) in the adjuvant setting after resection of hepatic metastases from colorectal cancer.
A total of eleven dose levels will be considered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose
Time Frame: 2 years
|
2 years
|
Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Nancy E. Kemeny, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2003
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
May 6, 2003
First Submitted That Met QC Criteria
May 6, 2003
First Posted (Estimated)
May 7, 2003
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protective Agents
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antidotes
- Vitamin B Complex
- Dexamethasone
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Calcium
- Levoleucovorin
- Floxuridine
Other Study ID Numbers
- 03-005
- MSKCC-03005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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