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Anti-metabolites
Chemotherapy with Medtronic Pump and Codman Catheter for Colorectal Cancer
Phase 2
Recruiting
Led By Hagen Kennecke, MD
Research Sponsored by Benaroya Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinically or radiographically confirmed extrahepatic disease
Participants ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether a Medtronic pump and Codman catheter device is a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver for patients with metastatic colorectal cancer or cholangiocarcinoma.
Who is the study for?
This trial is for adults with colorectal cancer or cholangiocarcinoma that has spread to the liver, without extrahepatic disease. Participants must have acceptable organ function and performance status, may have had prior chemotherapy but not recent radiation to the liver, and should not be pregnant or planning pregnancy soon.Check my eligibility
What is being tested?
The study tests if using a Medtronic pump with a Codman catheter is safe for delivering chemotherapy directly into the liver compared to the standard C3000 Codman pump in patients with specific types of liver metastases.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, and possible complications from device use like infection at the catheter site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My colorectal cancer has spread to my liver and not beyond.
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I am 18 years old or older.
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I had my last chemotherapy with oxaliplatin or irinotecan more than 3 weeks ago.
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I am fully active and can carry on all pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients requiring stent replacements
Percent frequency liver toxicity
Secondary outcome measures
Overall survival
Progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pump TherapyExperimental Treatment7 Interventions
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Find a Location
Who is running the clinical trial?
Benaroya Research InstituteLead Sponsor
45 Previous Clinical Trials
11,217 Total Patients Enrolled
Virginia Mason Hospital/Medical CenterOTHER
20 Previous Clinical Trials
3,326 Total Patients Enrolled
Hagen Kennecke, MDPrincipal InvestigatorVirginia mason medical Center
6 Previous Clinical Trials
618 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation to the liver, but may have had pelvic radiation completed over 4 weeks ago.I have had cancer before, but it was a different type than my current diagnosis.I do not have any serious wounds, ulcers, or unhealed bone fractures.My colorectal cancer has spread to my liver and not beyond.My cancer was treated over 3 years ago, with no current signs of it and considered low risk for coming back.I am 18 years old or older.My colorectal cancer is either BRAF mutant or has mismatch repair issues.I received 5-FU or 5-FU leucovorin treatment at least 2 weeks before starting this trial.My cervical cancer was treated and shows no signs of being present.I had skin cancer (not melanoma) or lentigo maligna, but it's now treated with no signs of the disease.I do not have a history of brain tumors, uncontrolled seizures, or strokes.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I had my last chemotherapy with oxaliplatin or irinotecan more than 3 weeks ago.I had liver metastases removed and have no signs of cancer elsewhere.I have a confirmed diagnosis of cholangiocarcinoma without recurrence in previously treated areas.I am fully active and can carry on all pre-disease activities without restriction.I do not have an active infection, fluid in my abdomen, or brain issues due to liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Pump Therapy
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have signed up to be a part of this experiment?
"That is accurate. The listing on clinicaltrials.gov for this trial says that it is still recruiting patients. This particular study was posted on November 25th, 2020 and 100 individuals are needed from 1 site."
Answered by AI
What else do we know about Gemcitabine from other research?
"1141 total clinical trials are currently studying Gemcitabine. 324 of those active studies are in Phase 3 testing. The majority of these gemcitabine research projects are based in Guangzhou, Guangdong; however, there are 50549 different locations around the world conducting trials for this medication."
Answered by AI
Are there any patients needed for this research program at the moment?
"Based on the information available on clinicaltrials.gov, it appears that this particular trial is still actively recruiting patients. It was first posted on November 25th 2020 and was last updated on December 17th 2020. The study is looking for 100 participants across 1 location."
Answered by AI
Are there any short or long term dangers associated with Gemcitabine?
"While there is some data supporting Gemcitabine's safety, it hasn't been proven effective yet and thus received a score of 2."
Answered by AI
What is the most popular reason that Gemcitabine is prescribed?
"Gemcitabine is frequently used to help patients with non-small cell lung carcinoma, but it has also been shown to improve quality of life for those struggling with rectal carcinoma, colorectal carcinoma, and sarcoma."
Answered by AI
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