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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03693807
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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?


Condition or disease Intervention/treatment Phase
Colorectal Cancer Cholangiocarcinoma 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) Phase 2

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, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. CT C/A/P every 2 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.

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, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Treatment will continue for 6 months in the absence of toxicity or patient withdrawal. CT C/A/P every 3 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.

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, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. A CT C/A/P every 2 months during treatment. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot non- randomized safety study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Protocol Evaluating Safety of Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Colorectal Carcinoma or Cholangiocarcinoma
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pump Therapy
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Device: Medtronic pump and Codman catheter
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.

Drug: Floxuridine (FUDR)
Please see Detailed Description.

Drug: Gemcitabine
Please see Detailed Description.

Drug: Oxaliplatin
Please see Detailed Description.

Drug: Irinotecan (CPT-11)
Please see Detailed Description.

Drug: Fluorouracil
Please see Detailed Description.

Drug: Anti-EGFR (Panitumumab or Cetuximab)
Please see Detailed Description.




Primary Outcome Measures :
  1. number of patients requiring stent replacements [ Time Frame: 1 year ]
  2. % frequency liver toxicity [ Time Frame: 1 year ]
    alkaline phosphatase, serum bilirubin


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first.

  2. progression free survival [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl 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 MSKCC
  • Patient may have completely resected hepatic metastases without current evidence of other metastatic disease
  • Lab values ≤14 days prior to registration:

    • WBC ≥2.5 K/uL
    • Platelets ≥100,000/uL
    • Creatinine <1.7mg/dL
    • HGB ≥ 8.5 gm/dL
    • Total Bilirubin ≤1.5 mg/dl
  • Prior chemotherapy is acceptable if last dose given ≥3 weeks prior to registration to this study. [Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study]
  • Any investigation agent is acceptable if administered ≥3 months before planned first dose on this protocol
  • KPS ≥60%
  • Patients ≥18 years of age

Exclusion Criteria:

  • 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)
  • Active infection, ascites, hepatic encephalopathy
  • Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start)
  • If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
  • Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis)
  • Patients 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:

    1. 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
    2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
    3. Adequately treated cervical carcinoma in situ without evidence of disease

There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693807


Contacts
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Contact: Nancy Kemeny, MD 646-888-4180 kemenyn@mskcc.org
Contact: William Jarnagin, MD 212-639-7601

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nancy Kemeny, MD    646-888-4180      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nancy Kemeny, MD    646-888-4180      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Nancy Kemeny, MD    646-888-4180      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Nancy Kemeny, MD, PhD    646-888-4180      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Nancy Kemeny, MD    646-888-4180      
Principal Investigator: Nancy Kemeny, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy Kemeny, MD    646-888-4180      
Principal Investigator: Nancy Kemeny, MD         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Nancy Kemeny, MD    646-888-4180      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Nancy Kemeny, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03693807     History of Changes
Other Study ID Numbers: 18-343
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Medtronic Pump
Codman Catheter
Hepatic Arterial Infusion (HAI)
Floxuridine (FUDR)
Gemcitabine
Oxaliplatin
Irinotecan (CPT-11)
Fluorouracil
Leucovorin Calcium (Folinic Acid)
Dexamethasone
18-343

Additional relevant MeSH terms:
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Colorectal Neoplasms
Cholangiocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Carcinoma
Gemcitabine
Fluorouracil
Floxuridine
Oxaliplatin
Irinotecan
Cetuximab
Panitumumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors