Description:
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?
Title
- 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 the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
CRP19045
- NCT ID:
NCT04668976
Conditions
- Colorectal Cancer
- Cholangiocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
Floxuridine (FUDR) | | Pump Therapy |
Gemcitabine | | Pump Therapy |
Oxaliplatin | | Pump Therapy |
Irinotecan (CPT-11) | | Pump Therapy |
Fluorouracil | | Pump Therapy |
Anti-EGFR (Panitumumab or Cetuximab) | | Pump Therapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Pump Therapy | Experimental | All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. | - Floxuridine (FUDR)
- Gemcitabine
- Oxaliplatin
- Irinotecan (CPT-11)
- Fluorouracil
- Anti-EGFR (Panitumumab or Cetuximab)
|
Eligibility Criteria
Inclusion Criteria:
1. 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)
2. Confirmation of diagnosis must be performed at VMMC
3. Participant may have completely resected hepatic metastases without current evidence
of other metastatic disease
4. 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
5. 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]
6. Any investigation agent is acceptable if administered ≥3 months before planned first
dose on this protocol
7. ECOG <=1
8. Participants ≥18 years of age
Exclusion Criteria:
1. 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)
2. Colorectal cancer that is BRAF mutant or defective in mismatch repair.
3. Active infection, ascites, hepatic encephalopathy
4. 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)
5. If in the opinion of the treating investigator a participant has any serious medical
problems which may preclude receiving this type of treatment
6. Participants with current evidence of hepatitis A, B, C (i.e., active hepatitis)
7. 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
8. Serious or non-healing active wound, ulcer, or bone fracture
9. 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 malignant without
evidence of disease
3. Adequately treated cervical carcinoma in situ without evidence of disease
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of patients requiring stent replacements |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Alkaline phosphatase percent toxicity, Serum bilirubin percent toxicity |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first. |
Measure: | Progression free survival |
Time Frame: | 1 year |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Benaroya Research Institute |
Trial Keywords
- Medtronic Pump
- Codman Catheter
- Hepatic Arterial Infusion (HAI)
- Floxuridine (FUDR)
- Gemcitabine
- Oxaliplatin
- Irinotecan (CPT-11)
- Fluorouracil
- Leucovorin Calcium (Folinic Acid)
- Dexamethasone
Last Updated
December 21, 2020