Brief Title
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
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
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, 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
number of patients requiring stent replacements
Secondary Outcome
Overall survival
Condition
Colorectal Cancer
Intervention
Medtronic pump and Codman catheter
Study Arms / Comparison Groups
Pump Therapy
Description: All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
35
Start Date
October 18, 2018
Completion Date
September 2022
Primary Completion Date
September 2022
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nancy Kemeny, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03693807
Organization ID
18-343
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Nancy Kemeny, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
November 2021