← Back to Search

Chemotherapy

Chemotherapy Delivery System for Colorectal and Bile Duct Cancers

Phase 2
Waitlist Available
Led By Nancy Kemeny, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≥18 years of age
History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinically or radiographically confirmed extrahepatic disease
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 to patients with metastatic colorectal cancer or cholangiocarcinoma.

Who is the study for?
This trial is for adults with colorectal carcinoma or cholangiocarcinoma metastatic to the liver. They must have a confirmed diagnosis, acceptable organ function tests, and no extrahepatic disease. Prior chemotherapy is allowed if it was over 3 weeks ago, but not after liver lesion resection before this study.Check my eligibility
What is being tested?
The study investigates whether using the Medtronic pump combined with Codman catheter is a safe method for delivering chemotherapy directly into the liver compared to the standard C3000 Codman pump in patients with specific types of cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, and possible device-related complications like infection at the catheter site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My colorectal cancer has spread to my liver and not beyond.
Select...
My bile duct cancer was removed and hasn't returned in that area.
Select...
I can care for myself but may need occasional assistance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
% frequency liver toxicity
number of patients requiring stent replacements
Secondary outcome measures
Overall survival
progression free survival

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Dyspnoea
1%
Cerebral infarction
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

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
Oxaliplatin
2011
Completed Phase 4
~2560
Gemcitabine
2017
Completed Phase 3
~2070
Fluorouracil
2014
Completed Phase 3
~11540

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,876 Total Patients Enrolled
Nancy Kemeny, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
127 Total Patients Enrolled
~1 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top