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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

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I am 18 years old or older.

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My colorectal cancer has spread to my liver and not beyond.

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My bile duct cancer was removed and hasn't returned in that area.

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I can care for myself but may need occasional assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,820 Total Patients Enrolled

Nancy Kemeny, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

127 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most frequent indications for Gemcitabine?

"Gemcitabine is a medication that oncologists often prescribe to patients with non-small cell lung carcinoma. Additionally, it can ameliorate certain side effects of rectal carcinoma, colorectal carcinoma, and sarcoma."

Answered by AI

Does Gemcitabine have a good safety profile?

"While Phase 2 trials don't have the same level of data supporting efficacy, Gemcitabine's safety was estimated to be a 2."

Answered by AI

Are there any other existing clinical trials that feature Gemcitabine?

"There are a total of 1142 clinical trials currently underway that involve Gemcitabine. 324 of these trials have reached Phase 3. Many studies are based in Guangzhou, Guangdong; however, there are over 50,000 locations worldwide where clinical trials for Gemcitabine are taking place."

Answered by AI

Do many hospitals in North America offer this particular treatment?

"To limit travel-related difficulties, patients are encouraged to select a trial site location nearest to them from the 7 available. The locations include Uniondale, Basking Ridge and Middletown among others."

Answered by AI

How many people are being asked to participate in this trial?

"This study is not recruiting at the moment. The listing was first posted on October 18th, 2018 and was last updated 3rd October, 2022. If you're interested in other trials, there are 1291 clinical trials actively recruiting patients with cholangiocarcinoma and 1142 trials for Gemcitabine that are looking for participants."

Answered by AI

Are there any open positions for patients in this clinical trial?

"As of now, this clinical trial is not admitting patients. However, it is worth noting that the study was last updated on 10/3/2022 and was originally posted on 10/18/2018. Additionally, if you are looking for other trials, 1291 studies involving cholangiocarcinoma and 1142 Gemcitabine trials are still enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

2018. "A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03693807.

All > Intrahepatic Cholangiocarcinoma > Colorectal Cancer