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

Last updated: December 17, 2020
Sponsor: Benaroya Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Rectal Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT04668976
CRP19045
  • Ages > 18
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. History of histologically confirmed colorectal adenocarcinoma metastatic to the liverwith no clinically or radiographically confirmed extrahepatic disease (or)Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence ofmetastatic disease that has been resected is allowed, provided there is no recurrencein 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 evidenceof 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 referencevalue 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 ≥3weeks prior to planned first dosing on this protocol. 5-FU or 5-FU leucovorin may begiven ≥2 weeks prior to planned first dosing on this protocol. [Note: no chemotherapyto 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 firstdose on this protocol
  7. ECOG <=1
  8. Participants ≥18 years of age

Exclusion

Exclusion Criteria:

  1. Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable ifcompeted 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 pregnantwithin 6 months after the end of the treatment (female participants of child-bearingpotential must have negative pregnancy test ≤72 hours before treatment start)
  5. If in the opinion of the treating investigator a participant has any serious medicalproblems 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:
  10. Malignancy treated with curative intent and with no known active disease presentfor ≥3 years prior to registration and felt to be at low risk for recurrence bythe treating physician
  11. Adequately treated non-melanomatous skin cancer or lentigo malignant withoutevidence of disease
  12. Adequately treated cervical carcinoma in situ without evidence of disease

Study Design

Total Participants: 100
Study Start date:
November 25, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Virginia mason medical Center

    Seattle, Washington 98101
    United States

    Active - Recruiting

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