Colorectal CancerPhase 2NCT04668976
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
A Phase 2 study testing Medtronic pump and Codman catheter, Floxuridine (FUDR) and Gemcitabine in people with Colorectal Cancer and Cholangiocarcinoma, run by Benaroya Research Institute at 1 site in United States.
Trial summary
This study is being done to answer the following question: Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Cholangiocarcinoma
- What is being tested?
- Medtronic pump and Codman catheter, Floxuridine (FUDR) and Gemcitabine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinically or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent)
- Confirmation of diagnosis must be performed at VMMC
- Participant may have completely resected hepatic metastases without current evidence of other metastatic disease
- Lab values ≤14 days prior to registration:
- ANC ≥ 1.0(9)/L Platelet count ≥ 75 (9)/L Creatinine ≤1.8 mg/dL AST 0 to 2x reference value ALK PHOS 0 to < 1.2 x reference value Tot Bili 0 to < 1.2 x reference value
- Prior chemotherapy is acceptable if last dose of oxaliplatin or irinotecan is given ≥3 weeks prior to planned first dosing on this protocol. 5-FU or 5-FU leucovorin may be given ≥2 weeks prior to planned first dosing on this protocol. [Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study]
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- Any investigation agent is acceptable if administered ≥3 months before planned first dose on this protocol
- ECOG <=1
- Participants ≥18 years of age
Who cannot join
- Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol)
- Colorectal cancer that is BRAF mutant or defective in mismatch repair.
- Active infection, ascites, hepatic encephalopathy
- Female participants who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female participants of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start)
- If in the opinion of the treating investigator a participant has any serious medical problems which may preclude receiving this type of treatment
- Participants with current evidence of hepatitis A, B, C (i.e., active hepatitis)
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- Participants with history or known presence of primary CNS tumors, seizures not well- controlled with standard medical therapy, or history of stroke will also be excluded
- Serious or non-healing active wound, ulcer, or bone fracture
- History of other malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for ≥3 years prior to registration and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanomatous skin cancer or lentigo malignant without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Virginia mason medical Center
Seattle, Washington, 98101
Hagen Kennecke, MD, 206-223-6193, Hagen.Kennecke@virginiamason.org
Hagen Kennecke, MD
About this study
Official title: A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma
This study is being done to answer the following question:
Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?
Read the detailed description
Group 1 unresectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
Group 2 resectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
Group 3 unresectable cholangiocarcinoma
- Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
- Conditions
- Colorectal Cancer, Cholangiocarcinoma
- Being tested
- Medtronic pump and Codman catheter, Floxuridine (FUDR), Gemcitabine, Oxaliplatin, Irinotecan (CPT-11)
- Keywords
- Medtronic Pump, Codman Catheter, Hepatic Arterial Infusion (HAI), Floxuridine (FUDR), Gemcitabine, Oxaliplatin, Irinotecan (CPT-11), Fluorouracil, Leucovorin Calcium (Folinic Acid), Dexamethasone
- Medical subject headings
- Colorectal Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic pump and Codman catheterDevice
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR)Drug
Please see Detailed Description.
GemcitabineDrug
Please see Detailed Description.
OxaliplatinDrug
Please see Detailed Description.
Irinotecan (CPT-11)Drug
Please see Detailed Description.
FluorouracilDrug
Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab)Drug
Please see Detailed Description.
| Study group | Role | What they receive |
|---|---|---|
| Pump Therapy | Experimental | All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. Receives: Device: Medtronic pump and Codman catheter; Drug: Floxuridine (FUDR); Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Irinotecan (CPT-11); Drug: Fluorouracil; Drug: Anti-EGFR (Panitumumab or Cetuximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring stent replacements
Measured: 1 year
Percent frequency liver toxicity
Alkaline phosphatase percent toxicity, Serum bilirubin percent toxicity
Measured: 1 year
Secondary outcomes (2)
Overall survival
Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first.
Measured: 1 year
Progression free survival
Progression free survival is defined as the time from treatment initiation till the day of progression or death whichever occurs first. Patients that are alive without progression at the end of the study will be censored.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start25 Nov 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot non- randomized safety study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Responsible party
- Sponsor
- Investigators
- Hagen Kennecke, MD, Principal investigator, Virginia mason medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668976
- Sponsor's protocol ID
- CRP19045
- Status last verified
- Dec 2020
- First submitted
- 6 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT04668976
- Acronym / sponsor ID
- CRP19045
- Conditions
- Colorectal Cancer, Cholangiocarcinoma
- Keywords
- Medtronic Pump, Codman Catheter, Hepatic Arterial Infusion (HAI), Floxuridine (FUDR), Gemcitabine, Oxaliplatin, Irinotecan (CPT-11), Fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to answer the following question:
Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?
Detailed description
Group 1 unresectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
Group 2 resectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
Group 3 unresectable cholangiocarcinoma
- Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot non- randomized safety study
| Arm | Type | Receives |
|---|---|---|
| Pump Therapy | Experimental | Device: Medtronic pump and Codman catheter, Drug: Floxuridine (FUDR), Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Irinotecan (CPT-11), Drug: Fluorouracil, Drug: Anti-EGFR (Panitumumab or Cetuximab)All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinically or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent)
- Confirmation of diagnosis must be performed at VMMC
- Participant may have completely resected hepatic metastases without current evidence of other metastatic disease
- Lab values ≤14 days prior to registration:
- ANC ≥ 1.0(9)/L Platelet count ≥ 75 (9)/L Creatinine ≤1.8 mg/dL AST 0 to 2x reference value ALK PHOS 0 to < 1.2 x reference value Tot Bili 0 to < 1.2 x reference value
Key exclusion criteria (12 listed)
- Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol)
- Colorectal cancer that is BRAF mutant or defective in mismatch repair.
- Active infection, ascites, hepatic encephalopathy
- Female participants who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female participants of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start)
- If in the opinion of the treating investigator a participant has any serious medical problems which may preclude receiving this type of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic pump and Codman catheterAll patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. | Device | Pump Therapy |
| Floxuridine (FUDR)Please see Detailed Description. | Drug | Pump Therapy |
| GemcitabinePlease see Detailed Description. | Drug | Pump Therapy |
| OxaliplatinPlease see Detailed Description. | Drug | Pump Therapy |
| Irinotecan (CPT-11)Please see Detailed Description. | Drug | Pump Therapy |
| FluorouracilPlease see Detailed Description. | Drug | Pump Therapy |
| Anti-EGFR (Panitumumab or Cetuximab)Please see Detailed Description. | Drug | Pump Therapy |
Primary outcome
Number of patients requiring stent replacements
Time frame: 1 year
Percent frequency liver toxicity
Time frame: 1 year
Alkaline phosphatase percent toxicity, Serum bilirubin percent toxicity
2 secondary outcomes
Overall survival
Time frame: 1 year
Progression free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagen Kennecke, MD principal investigator
Virginia mason medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medtronic pump and Codman catheter, Floxuridine (FUDR) and Gemcitabine in people with Colorectal Cancer and Cholangiocarcinoma, run by Benaroya Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagen Kennecke, MD (206-223-6193, Hagen.Kennecke@virginiamason.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients requiring stent replacements (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.