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

NCT04668976 | Unknown Phase 2 FDA Drug FDA Device

• 1 other identifier: CRP19045
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (2)

• Number of patients requiring stent replacements

  1 year

• Percent frequency liver toxicity

  Alkaline phosphatase percent toxicity, Serum bilirubin percent toxicity

  1 year

Secondary Outcomes (2)

• Overall survival

  1 year

• Progression free survival

  1 year

Study Arms (1)

Pump Therapy

EXPERIMENTAL

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

Device: Medtronic pump and Codman catheter; Drug: Floxuridine (FUDR); Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Irinotecan (CPT-11); Drug: Fluorouracil; Drug: Anti-EGFR (Panitumumab or Cetuximab)

Interventions

Medtronic pump and Codman catheter DEVICE

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

Pump Therapy

Floxuridine (FUDR) DRUG

Please see Detailed Description.

Pump Therapy

Gemcitabine DRUG

Please see Detailed Description.

Pump Therapy

Oxaliplatin DRUG

Please see Detailed Description.

Pump Therapy

Irinotecan (CPT-11) DRUG

Please see Detailed Description.

Pump Therapy

Fluorouracil DRUG

Please see Detailed Description.

Pump Therapy

Anti-EGFR (Panitumumab or Cetuximab) DRUG

Please see Detailed Description.

Pump Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Confirmation of diagnosis must be performed at VMMC
• Participant may have completely resected hepatic metastases without current evidence of other metastatic disease
• 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
• 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. \[Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study\]
• Any investigation agent is acceptable if administered ≥3 months before planned first dose on this protocol
• ECOG \<=1
• Participants ≥18 years of age

You may not qualify if:

• 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)
• Colorectal cancer that is BRAF mutant or defective in mismatch repair.
• Active infection, ascites, hepatic encephalopathy
• 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)
• If in the opinion of the treating investigator a participant has any serious medical problems which may preclude receiving this type of treatment
• Participants with current evidence of hepatitis A, B, C (i.e., active hepatitis)
• 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
• Serious or non-healing active wound, ulcer, or bone fracture
• History of other malignancy, except:
• 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
• Adequately treated non-melanomatous skin cancer or lentigo malignant without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia mason medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Cholangiocarcinoma

Interventions

Floxuridine; Gemcitabine; Oxaliplatin; Irinotecan; Fluorouracil; Panitumumab; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Uracil; Pyrimidinones; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hagen Kennecke, MD

  Virginia mason medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagen Kennecke, MD

CONTACT

206-223-6193; Hagen.Kennecke@virginiamason.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot non- randomized safety study

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 16, 2020
• Study Start: November 25, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)