Clinical trial NCT03693807: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Cholangiocarcinoma
Keywords: Medtronic Pump
Codman Catheter
Hepatic Arterial Infusion (HAI)
Floxuridine (FUDR)
Gemcitabine
Oxaliplatin
Irinotecan (CPT-11)
Fluorouracil
Leucovorin Calcium (Folinic Acid)
Dexamethasone
18-343
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot non- randomized safety study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: number of patients requiring stent replacements
timeFrame: 1 year
measure: % frequency liver toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: progression free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Kemeny, MD
role: PRINCIPAL_INVESTIGATOR
References: