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

NCT ID: NCT04668976

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2024-12-31

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.

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pump Therapy

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

Group Type: EXPERIMENTAL

Medtronic pump and Codman catheter

Intervention Type: DEVICE

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

Floxuridine (FUDR)

Intervention Type: DRUG

Please see Detailed Description.

Gemcitabine

Intervention Type: DRUG

Please see Detailed Description.

Oxaliplatin

Intervention Type: DRUG

Please see Detailed Description.

Irinotecan (CPT-11)

Intervention Type: DRUG

Please see Detailed Description.

Fluorouracil

Intervention Type: DRUG

Please see Detailed Description.

Anti-EGFR (Panitumumab or Cetuximab)

Intervention Type: DRUG

Please see Detailed Description.

Interventions

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.

Intervention Type: DEVICE

Floxuridine (FUDR)

Please see Detailed Description.

Intervention Type: DRUG

Gemcitabine

Please see Detailed Description.

Intervention Type: DRUG

Oxaliplatin

Please see Detailed Description.

Intervention Type: DRUG

Irinotecan (CPT-11)

Please see Detailed Description.

Intervention Type: DRUG

Fluorouracil

Please see Detailed Description.

Intervention Type: DRUG

Anti-EGFR (Panitumumab or Cetuximab)

Please see Detailed Description.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagen Kennecke, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia mason medical Center

Locations

Virginia mason medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hagen Kennecke, MD

Role: CONTACT

Phone: 206-223-6193

Email: Hagen.Kennecke@virginiamason.org

Facility Contacts

Hagen Kennecke, MD

Role: primary

Other Identifiers

CRP19045

Identifier Type: -

Identifier Source: org_study_id