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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

number of patients requiring stent replacements[ Time Frame: 1 year ]

% frequency liver toxicity[ Time Frame: 1 year ]

alkaline phosphatase, serum bilirubin

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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?

Detailed Description

Group 1 unresectable liver metastases from colorectal cancer - Patients will receive either FOLFIRI, FOLFOX, 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. 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, 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot non- randomized safety study.
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2020

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease (or) Histologically confirmed cholangiocarcinoma - 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 ≥3.0 K/uL - ANC >1.5 K/uL - Platelets ≥100,000/uL - Creatinine <1.5mg/dL - HGB ≥ 9 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 registration - 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 registration) - 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 registration) - 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Memorial Sloan Kettering Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Nancy Kemeny, MD Memorial Sloan Kettering Cancer Center

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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